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Sample records for premarket applications pmas

  1. 78 FR 19714 - User Fees and Refunds for Premarket Approval Applications and Device Biologics License...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``User Fees and Refunds for Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs).'' The purpose of this guidance document is to identify the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that do not......

  2. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... premarket approval application (PMA) file. 814.9 Section 814.9 Food and Drugs FOOD AND DRUG ADMINISTRATION... General § 814.9 Confidentiality of data and information in a premarket approval application (PMA) file. (a) A “PMA file” includes all data and information submitted with or incorporated by reference in...

  3. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... premarket approval application (PMA) file. 814.9 Section 814.9 Food and Drugs FOOD AND DRUG ADMINISTRATION... General § 814.9 Confidentiality of data and information in a premarket approval application (PMA) file. (a) A “PMA file” includes all data and information submitted with or incorporated by reference in...

  4. Science verification results from PMAS

    NASA Astrophysics Data System (ADS)

    Roth, M. M.; Becker, T.; Böhm, P.; Kelz, A.

    2004-02-01

    PMAS, the Potsdam Multi-Aperture Spectrophotometer, is a new integral field instrument which was commissioned at the Calar Alto 3.5m Telescope in May 2001. We report on results obtained from a science verification run in October 2001. We present observations of the low-metallicity blue compact dwarf galaxy SBS0335-052, the ultra-luminous X-ray Source X-1 in the Holmberg;II galaxy, the quadruple gravitational lens system Q2237+0305 (the ``Einstein Cross''), the Galactic planetary nebula NGC7027, and extragalactic planetary nebulae in M31. PMAS is now available as a common user instrument at Calar Alto Observatory.

  5. Experiences with the PMAS-IFUs

    NASA Astrophysics Data System (ADS)

    Kelz, Andreas; Roth, Martin M.

    2006-06-01

    The Potsdam Multi-Aperture Spectrophotometer (PMAS) at the 3.5 m Calar Alto Telescope features two Integral-Field Units (IFUs), that differ in their principle of operation and scientific application. For both units, optical fibers are used, which are either coupled to a microlens array, or densely-packed to form a bare bundle. The specifications, operational modes and performances of these field units are described, with a particular emphasis on fiber behavior and its impact on instrumental throughput and spectrophotometric stability.

  6. FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012

    PubMed Central

    Rome, Benjamin N.; Kramer, Daniel B.; Kesselheim, Aaron S.

    2014-01-01

    IMPORTANCE The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via “supplements,” which may not require additional clinical testing. OBJECTIVE To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. DESIGN Using the FDA’s PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories overtime. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. RESULTS From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device’s design. Among 180-day supplements approved from 2010

  7. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES... the safety and effectiveness of the device that is the subject of the PMA and that is the basis for... under § 20.61; and (ii) Any personnel, medical, and similar information disclosure of which...

  8. 78 FR 53151 - The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-28

    ... guidance answers commonly asked questions about the applicability of good laboratory practice (GLP) to.... SUPPLEMENTARY INFORMATION: I. Background FDA issued the GLP regulations in response to public concerns that... poor research practices and laboratory misconduct. The GLP regulations apply to nonclinical...

  9. Can You Diagnose Me Now? A Proposal to Modify FDA's Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database System.

    PubMed

    McInerney, Stephen

    2015-01-01

    Mobile applications provide limitless possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the Food and Drug Administration (FDA) has the authority to regulate a much broader spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if FDA has the statutory. authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, FDA published guidance on Mobile Medical Applications; in it, the Agency limited its oversight to a small subset of medical-related mobile applications, referred to as "mobile medical applications." For the guidance to be effective, FDA must continue to work directly with all actors--including innovators, doctors, and patients--as the market for mobile health applications continues to develop. This Article argues that FDA should adopt a two-step plan--a pre-market notification program and a mobile medical application database--to aid in the successful implementation of its 2013 guidance. By doing so, FDA will ensure that this burgeoning market can reach its fullest potential. PMID:26292476

  10. Commissioning of an integral-field spectro-polarimeter for PMAS

    NASA Astrophysics Data System (ADS)

    Lemke, Ulrike; Kelz, Andreas; Bauer, Svend M.; Hahn, Thomas; Popow, Emil; Roth, Martin M.

    2008-07-01

    During 2007, a new polarimetric observing mode was added to the existing integral-field spectrograph PMAS. Initially, this instrumental upgrade is aimed to measure the linear polarization states and to determine the three Stokes parameters I, Q and U. The PMAS instrument offers an integral-field of view of up to 256 square arcseconds, while the spectrograph covers a wavelength region from 340 to 900 nm. The paper presents the opto-mechanical design of the polarimetric unit, summarizes calibration and test results and describes the first data taken during commissioning at the Calar Alto observatory. Given the range of applications and the large parameter space (two spatial coordinates, one wavelength dimension, plus polarimetric information), the realization of the PMAS 2D-Spectro-Polarimeter provides a unique capability for night-time astrophysical observations, such as the study of scattering processes or magnetic fields for a range of astronomical targets.

  11. Ultra-deep Optical Spectroscopy with PMAS

    NASA Astrophysics Data System (ADS)

    Roth, M. M.; Fechner, T.; Wolter, D.; Kelz, A.; Becker, T.

    PMAS, the Potsdam Multi-Aperture Spectrophotometer, is a new integral field spectrograph in the optical, which is optimized for good transmission and high image quality from 350 nm to 1 mm. We present our plan to implement a CCD charge-shuffle mode to allow for beam switching with a very high degree of sky subtraction accuracy for faint object 3-D spectroscopy.

  12. Faint object 3D spectroscopy with PMAS

    NASA Astrophysics Data System (ADS)

    Roth, Martin M.; Becker, Thomas; Kelz, Andreas; Bohm, Petra

    2004-09-01

    PMAS is a fiber-coupled lens array type of integral field spectrograph, which was commissioned at the Calar Alto 3.5m Telescope in May 2001. The optical layout of the instrument was chosen such as to provide a large wavelength coverage, and good transmission from 0.35 to 1 μm. One of the major objectives of the PMAS development has been to perform 3D spectrophotometry, taking advantage of the contiguous array of spatial elements over the 2-dimensional field-of-view of the integral field unit. With science results obtained during the first two years of operation, we illustrate that 3D spectroscopy is an ideal tool for faint object spectrophotometry.

  13. PMAS - Faint Object 3D Spectrophotometry

    NASA Astrophysics Data System (ADS)

    Roth, M. M.; Becker, T.; Kelz, A.

    2002-01-01

    will describe PMAS (Potsdam Multiaperture Spectrophotometer) which was commissioned at the Calar Alto Observatory 3.5m Telescope on May 28-31, 2001. PMAS is a dedicated, highly efficient UV-visual integral field spectrograph which is optimized for the spectrophotometry of faint point sources, typically superimposed on a bright background. PMAS is ideally suited for the study of resolved stars in local group galaxies. I will present results of our preliminary work with MPFS at the Russian 6m Telescope in Selentchuk, involving the development of new 3D data reduction software, and observations of faint planetary nebulae in the bulge of M31 for the determination of individual chemical abundances of these objects. Using this data, it will be demonstrated that integral field spectroscopy provides superior techniques for background subtraction, avoiding the otherwise inevitable systematic errors of conventional slit spetroscopy. The results will be put in perspective of the study of resolved stellar populations in nearby galaxies with a new generation of Extremely Large Telescopes.

  14. 78 FR 44128 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... into class III by FDA are subject to premarket approval requirements. Premarket approval (PMA) is the.... An approved PMA is, in effect, a private license granted to the applicant for marketing a particular medical device. A class III device that fails to meet PMA requirements is considered to be...

  15. Performance of the PMAS 3D spectrophotometer

    NASA Astrophysics Data System (ADS)

    Roth, Martin M.; Kelz, Andreas

    2006-06-01

    Unlike some integral field units (IFUs) in front of conventional slit spectrographs, PMAS is a dedicated fiber-optical integral field spectrograph, featuring two different types of IFUs to address both high spatial resolution and wide field-of-view (FoV) in a single instrument. The instrument was designed, built, and tested completely in-house at the Astrophysical Institute Potsdam from 1996 to 2000. It was commissioned at the Calar Alto 3.5m Telescope in May 2001. PMAS employs an all-refractive fiber spectrograph, built with CaF II optics, to provide good transmission and high image quality over the entire nominal wavelength range. A set of user-selectable reflective gratings provides low to medium spectral resolution in first order of approx. 1.5, 3.2, and 7 Å, depending on the groove density (1200, 600, 300 gr/mm). The standard IFU uses a 16×16 element lens array, which provides seeing-limited sampling in a relatively small field-of-view (FOV) in one of three magnifications (8×8, 12×12, or 16×16 arcsec2, respectively). The additional fiber bundle IFU (PPak) expands the FOV to a hexagonal area with a footprint of 65×74 arcsec2.

  16. Supercontinuum light sources for use in astronomical instrumentation: a test with PMAS, the Potsdam multi-aperture spectrophotometer

    NASA Astrophysics Data System (ADS)

    Roth, Martin M.; Löhmannsröben, Hans-Gerd; Dosche, Carsten; Sandin, Christer; Reich, Oliver; Haynes, Roger; Leick, Lasse; Chávez Boggio, José M.; Kelz, Andreas

    2010-07-01

    Supercontinuum white light sources (SCLS) are intense, spatially coherent laser sources with a very broad and flat spectral energy distribution which have very quickly found ubiquitous use in optical laboratories. As photonics is now providing more and more applications for astronomical instrumentation, the possible use of SCLS as a calibration light source for spectroscopy has been tested. A standard industrial SCLS was coupled to the calibration unit of the PMAS integral field spectrophotometer and compared directly to the PMAS standard tungsten filament lamp that is normally used for calibration exposures. We report on comparative measurements concerning flux, spectral energy distribution, and temporal stability.

  17. Commissioning of the PMAS 3D-spectrograph

    NASA Astrophysics Data System (ADS)

    Kelz, Andreas; Roth, Martin M.; Becker, Thomas

    2003-03-01

    PMAS, the Potsdam Multi-Aperture Spectrophotometer, was successfully commissioned at the Calar Alto 3.5m telescope during 2001. PMAS is a medium-resolution, lensarray/fiber based integral field spectrograph, covering the whole optical wavelength range from 350 to 900 nm with optimized high efficiency in the blue. We review the commissioning activities and present the current status of this new instrument.

  18. Nod-shuffle 3D spectroscopy with PMAS

    NASA Astrophysics Data System (ADS)

    Roth, Martin M.; Fechner, Thomas; Becker, Thomas; Kelz, Andreas

    2004-09-01

    PMAS is a versatile integral field spectrograph based on the principle of a fiber-coupled lens array type of IFU. The instrument was commissioned at the Calar Alto 3.5m Telescope in May 2001. PMAS is offered as a common user instrument at Calar Alto since 2002. However, it has remained flexible enough to be used as a testbed for new observing techniques. Since the instrument is sensitive in the wavelength range from 0.35 to 1 μm, it is being used to experiment with faint object 3D spectroscopy for a variety of objects in stellar and extragalactic astronomy. Among these experiments, we have implemented a nod-shuffle mode of operation, which is a beam switching technique to achieve a high degree of sky subtraction accuracy. We describe the technical details of the special solution found for PMAS and first results obtained in test observations of faint haloes of planetary nebulae.

  19. FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.

    PubMed

    Jenson, Desmond; Lester, Joelle; Berman, Micah L

    2016-05-01

    Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process. PMID:27068243

  20. The PMAS Fiber Module: Design, Manufacture and Performance Optimization

    NASA Astrophysics Data System (ADS)

    Kelz, Andreas; Roth, Martin M.; Becker, Thomas; Bauer, Svend-Marian

    2003-02-01

    PMAS, the Potsdam Multi-Aperture Spectrophotometer, is a new integral field (IF or 3D) instrument. It features a lenslet/optical fiber type integral field module and a dedicated fiber spectrograph. As the instrumental emphasis is on photometric stability and high efficiency, good flat field characteristic across the integral field is needed. The PMAS fiber module is unique in the sense that the design allows the replacement of individual fibers. This property, together with the fact that the fibers are index-matched at both ends, makes it possible to achieve and maintain a high efficiency. We present the opto-mechanical design for this fiber-module and, using various data sets from previous observing runs, demonstrate the increase of performance as a result of the optimization of the fiber-components.

  1. Integral field spectrophotometry of gravitationally lensed QSOs with PMAS

    NASA Astrophysics Data System (ADS)

    Wisotzki, L.; Becker, T.; Christensen, L.; Jahnke, K.; Helms, A.; Kelz, A.; Roth, M. M.; Sánchez, S. F.

    2004-02-01

    We present spatially resolved spectrophotometric observations of multiply imaged QSOs, using the Potsdam Multi-Aperture Spectrophotometer (PMAS), with the intention to search for spectral differences between components indicative of either microlensing or dust extinction. For the quadruple QSO HE 0435-1223 we find that the continuum shapes are indistinguishable, therefore differential extinction is negligible. The equivalent widths of the broad emission lines are however significantly different, and we argue that this is most likely due to microlensing. Contrariwise, the two components of the well-known object UM 673 have virtually identical emission line properties, but the continuum slopes differ significantly and indicate different dust extinction along both lines of sight.

  2. Integral field spectroscopy of SN 2002er with PMAS

    NASA Astrophysics Data System (ADS)

    Christensen, L.; Becker, T.; Jahnke, K.; Kelz, A.; Roth, M. M.; Sánchez, S. F.; Wisotzki, L.

    2003-04-01

    We present observations of the Type Ia supernova SN 2002er during the brightening phase. The observations were performed with the Potsdam Multi Aperture Spectrophotometer (PMAS) integral field instrument. Due to the 8arcsecx8 arcsec field of view of the spectrograph an accurate background subtraction was possible. Results from analyses of the evolution of absorption features in comparisons with other SNe show that SN 2002er is a fairly bright Type Ia supernova with a peak brightness of MB=-19.6+/-0.1.

  3. 76 FR 48058 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ... the cost of PMA at approximately $1,000,000 (see, for example, 73 FR 7501, February 8, 2008), and we... set at $236,298 for a premarket application (PMA or PDP) (75 FR 45632 at 45643), so user fees would... classification of this device along with information submitted in response to the 515(i) order (74 FR...

  4. 76 FR 48062 - Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ... a premarket application (PMA or PDP) and $2,174 for a 510(k) submission (75 FR 45641 at 45643). Thus... device along with information submitted in response to the 515(i) Order, (74 FR 16214, April 9, 2009... published in the Federal Register on these dates: November 28, 1974 (43 FR 55716), September 4, 1979 (44...

  5. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... HUMAN SERVICES Food and Drug Administration Content of Premarket Submissions for Management of... Administration (FDA) is announcing the availability of the draft guidance entitled ``Content of Premarket... draft guidance document entitled ``Content of Premarket Submissions for Management of Cybersecurity...

  6. The PMAS Telescope Module: Opto-mechanical Design and Manufacture

    NASA Astrophysics Data System (ADS)

    Roth, Martin M.; Laux, Uwe; Kelz, Andreas; Dionies, Frank

    2003-02-01

    PMAS, the Potsdam Multi-Aperture Spectrophotometer, has a modular layout which was intended to provide for flexible operation as a travelling instrument and to accomodate different telescopes. The Telescope Module is the part of the instrument which serves the purpose of mechanical and optical interfacing to the telescope. It contains optical systems to re-image the telescope focal plane onto the lens array, to illuminate the lens array from an internal calibration light source, and to observe an area around the 3D spectroscopy field-of-view with a cryogenic CCD system for acquisition, guiding, and for the simultaneous determination of point-spread-function templates for 3D deconvolution. We discuss the opto-mechanical design and manufacture of these subsystems.

  7. Effective date of requirement for premarket approval for automated external defibrillator systems. Final rule.

    PubMed

    2015-01-29

    The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use). PMID:25730922

  8. 77 FR 39924 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... cost of a PMA at approximately $1,000,000 (see, for example, 73 FR 7501, February 8, 2008), and we... application (PMA or PDP) (75 FR 45643), so user fees will likely cover $4.3 million (= 18 x $236,298) to $5.4... premarket approval. In the Federal Register of May 6, 1994 (59 FR 23731) (the May 6, 1994, notice),...

  9. The Disk Mass project; science case for a new PMAS IFU module

    NASA Astrophysics Data System (ADS)

    Verheijen, M. A. W.; Bershady, M. A.; Andersen, D. R.; Swaters, R. A.; Westfall, K.; Kelz, A.; Roth, M. M.

    2004-03-01

    We present our Disk Mass project as the main science case for building a new fiber IFU-module for the PMAS spectrograph, currently mounted at the Cassegrain focus of the 3.5m telescope on Calar Alto. Compared to traditional long-slit observations, the large light collecting power of 2-dimensional Integral Field Units dramatically improves the prospects for performing spectroscopy on extended low surface brightness objects with high spectral resolution. This enables us to measure stellar velocity dispersions in the outer disk of normal spiral galaxies. We describe some results from a PMAS pilot study using the existing lenslet array, and provide a basic description of the new fiber IFU-module for PMAS.

  10. Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair. Final order.

    PubMed

    2016-01-01

    The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair. PMID:26742183

  11. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ingredient that is the subject of the premarket notification, including the Latin binomial name (including... part of the material submitted is in a foreign language, it shall be accompanied by an accurate...

  12. Ultra-Deep Optical Spectroscopy with PMAS. Using the Nod-and-Shuffle Technique

    NASA Astrophysics Data System (ADS)

    Roth, Martin M.; Fechner, Thomas; Wolter, Dieter; Kelz, Andreas; Becker, Thomas

    2002-10-01

    PMAS, the Potsdam Multi-Aperture Spectrophotometer, is a new integral field spectrograph in the optical, which is optimized for good transmissionand high image quality from 350 nm to 1 μm. We present our plan to implementa CCD charge-shuffle mode to allow for beam switching with a very high degreeof sky subtraction accuracy for faint object 3-D spectroscopy.

  13. Commissioning of the CCD231 4K×4K detector for PMAS

    NASA Astrophysics Data System (ADS)

    Roth, Martin M.; Fechner, Thomas; Wolter, Dieter; Sandin, Christer; Kelz, Andreas; Bauer, Svend M.; Popow, Emil; Monreal-Ibero, Ana; Kehrig, Carolina; Streicher, Ole

    2010-07-01

    The PMAS integral field spectrophotometer, operated at the Calar Alto Observatory 3.5m Telescope, is one of the most demanded instruments of its kind. The optical system was designed for a camera field of view to accommodate a 4K×4K detector with 15μm pixels. However, due to a failure of one of the initially foreseen 2K×4K CCDs in a mosaic configuration, only half of the available field of view could be covered to date. Owing to the high demand from the user community, an upgrade to the full complement of 4K×4K pixels was envisaged, based on the availability of the new e2v CCD231 device. We describe the specification, implementation, test, and commissioning of this new detector for PMAS.

  14. PMAS: The Potsdam Multi-Aperture Spectrophotometer. I. Design, Manufacture, and Performance

    NASA Astrophysics Data System (ADS)

    Roth, Martin M.; Kelz, Andreas; Fechner, Thomas; Hahn, Thomas; Bauer, Svend-Marian; Becker, Thomas; Böhm, Petra; Christensen, Lise; Dionies, Frank; Paschke, Jens; Popow, Emil; Wolter, Dieter; Schmoll, Jürgen; Laux, Uwe; Altmann, Werner

    2005-06-01

    We describe the design, manufacture, commissioning, and performance of PMAS, the Potsdam Multi-Aperture Spectrophotometer. PMAS is a dedicated integral field spectrophotometer optimized to cover the optical wavelength regime of 0.35-1 μm. It is based on the lens array-fiber bundle principle of operation. The instrument employs an all-refractive fiber spectrograph, built with CaF2 optics, to provide good transmission and high image quality over the entire nominal wavelength range. A set of user-selectable reflective gratings provides low to medium spectral resolution of approximately 1.5, 3.2, and 7 Å in first order, depending on the groove density (1200, 600, 300 grooves mm-1). While the standard integral field unit (IFU) uses a 16×16 element lens array, which provides seeing-limited sampling in a relatively small field of view (FOV) in one of three magnifications (8" × 8", 12" × 12", or 16" × 16"), a recently retrofitted bare fiber bundle IFU (PPak: PMAS fiber pack) expands the FOV to a hexagonal area with a footprint of 65" × 74". Other special features include a cryogenic CCD camera for field acquisition and guiding, a nod-shuffle mode for beam switching and improved sky background subtraction, and a scanning Fabry-Pérot etalon in combination with the standard IFU (PYTHEAS mode). PMAS was initially designed and built as an experimental traveling instrument with optical interfaces to various telescopes (Calar Alto 3.5 m, ESO VLT, LBT). It is offered as a common-user instrument at Calar Alto under contract to MPIA Heidelberg since 2002.

  15. The Parent Mealtime Action Scale revised (PMAS-R): Psychometric characteristics and associations with variables of clinical interest.

    PubMed

    Hendy, Helen; Harclerode, Whitney; Williams, Keith E

    2016-10-01

    The purpose of the present study was to provide a revised and more psychometrically-examined version of the Parent Mealtime Action Scale (PMAS-R), then to examine how well the PMAS-R subscales explained variance for four variables relevant in clinical settings. Study participants included 238 parents of children referred to a hospital-based feeding program (72.3% male children; mean age = 72.2 months; 80 with autism spectrum disorder, 77 with other special needs, 81 with no special needs). Parents completed questionnaires to report child demographics and diet habits. Parents also used a five-point rating instead of the original three-point rating to report their usage of the 31 PMAS feeding practices. Using five-point ratings, the nine subscales of the PMAS-R demonstrated improved internal reliability and test-retest reliability compared to those published for the original PMAS. ANCOVA indicated that special needs status was the child demographic variable most associated with PMAS-R feeding practices. Hierarchical multiple regression revealed that after controlling for child demographics, the nine PMAS-R subscales explained 26-49% of the variance for four variables of clinical interest (fruit and vegetable consumption, snack consumption, total food variety, and weight status). These variables of clinical interest were most often associated with "permissive" feeding practices including low Daily Fruit and Vegetable (FV) Availability, rarely using Insistence on Eating during meals, often using Many Food Choices, and often using Child-Selected Meals. The present study provides a more psychometrically-sound measure of child feeding practices, documents the association between "permissive feeding" and variables of clinical interest, and identifies specific parent practices included in "permissive feeding". PMID:27221356

  16. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Requirement for premarket notification. 190.6 Section 190.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient...

  17. PMAS: The Potsdam Multi-Aperture Spectrophotometer. II. The Wide Integral Field Unit PPak

    NASA Astrophysics Data System (ADS)

    Kelz, Andreas; Verheijen, Marc A. W.; Roth, Martin M.; Bauer, Svend M.; Becker, Thomas; Paschke, Jens; Popow, Emil; Sánchez, Sebastian F.; Laux, Uwe

    2006-01-01

    PPak is a new fiber-based integral field unit (IFU) developed at the Astrophysical Institute of Potsdam and implemented as a module into the existing Potsdam Multi-Aperture Spectrophotometer (PMAS) spectrograph. The purpose of PPak is to provide an extended field of view with a large light-collecting power for each spatial element, as well as an adequate spectral resolution. The PPak system consists of a fiber bundle with 331 object fibers, 36 sky fibers, and 15 calibration fibers. The object and sky fibers collect the light from the focal plane behind a focal reducer lens. The object fibers of PPak, each 2.7" in diameter, provide a contiguous hexagonal field of view of 74" × 64" on the sky, with a filling factor of 60%. The operational wavelength range is from 400 to 900 nm. The PPak IFU, together with the PMAS spectrograph, are intended for the study of extended, low surface brightness objects, offering an optimization of total light-collecting power and spectral resolution. This paper describes the instrument design, the assembly, integration, and tests, the commissioning and operational procedures, and presents the measured performance at the telescope.

  18. Lights out on federal power: A plan to privatize the PMAs

    SciTech Connect

    Block, M.K.; Shadegg, J.

    1997-11-01

    Privatizing the power marketing administrations makes sense. Unless these federal administrations are sold, taxpayers will continue to subsidize power to the rich, and the PMAs will distort and hinder competition in the electric energy market. Employ this plan today and it will be possible to achieve benefits for all stakeholders. If there were a book entitled Privatization in The United States, it would be very thin indeed. It would be so partly because America did not participate as extensively as most countries in this century`s destructive experiment where governments produced goods that would be more efficiently produced by the private sector. Unfortunately, the book also would be thin because Americans have been less aggressive and imaginative than countries from Great Britain to Bolivia in withdrawing their national government from activities better suited to the private sector. One obvious target for immediate privatization is the federal electric power resources. This article proposes a politically viable plan to expand privatization in America by selling three of the federal government`s power marketing administrations. The PMAs, as they are known to the cognoscenti, market power generated by federally owned dams. Currently, the federal government is the nation`s largest producer and transmitter of electricity. While the government`s involvement in the electricity industry was once justified, these reasons no longer exist.

  19. 21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADDITIVES Premarket Notifications § 170.102 Confidentiality of information in a premarket notification for a... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND...

  20. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADDITIVES Premarket Notifications § 170.103 Withdrawal without prejudice of a premarket notification for a... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND...

  1. 21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADDITIVES Premarket Notifications § 170.102 Confidentiality of information in a premarket notification for a... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND...

  2. 21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADDITIVES Premarket Notifications § 170.102 Confidentiality of information in a premarket notification for a... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND...

  3. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADDITIVES Premarket Notifications § 170.103 Withdrawal without prejudice of a premarket notification for a... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND...

  4. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADDITIVES Premarket Notifications § 170.103 Withdrawal without prejudice of a premarket notification for a... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND...

  5. 21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADDITIVES Premarket Notifications § 170.102 Confidentiality of information in a premarket notification for a... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND...

  6. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADDITIVES Premarket Notifications § 170.103 Withdrawal without prejudice of a premarket notification for a... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND...

  7. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability... Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays.'' This draft... zonisamide assays. This draft guidance is not final nor is it in effect at this time. DATES: Although you...

  8. 21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.104 Action on a.... (d) If FDA and a manufacturer or supplier agree that the notifier may submit a food additive petition... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Action on a premarket notification for a...

  9. 21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.101...

  10. 77 FR 37573 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-22

    ... subject to the requirements of premarket approval. In the Federal Register of May 6, 1994 (59 FR 23731... premarket approval. ] In the Federal Register of July 27, 2011 (76 FR 44872) (the July 27, 2011, proposed... submitted in response to the 515(i) Order, (April 9, 2009 (74 FR 16214)), and any additional...

  11. 76 FR 78930 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... guidance published in the Federal Register on July 12, 2011 (76 FR 40921), and the comment period closed on...; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology... for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.''...

  12. Use and recognition of consensus standards in US premarket submissions.

    PubMed

    Donawa, M E

    1999-03-01

    In the autumn of 1997, the United States Center for Devices and Radiological Health published a draft guidance document on the use of IEC 60,601 standards in the evaluation of pre-market submissions for electromedical devices. One year later, an important legislative reform act caused this draft to be withdrawn because it allowed the Food and Drug Administration (FDA) to formally recognize standards covering all types of medical devices and not just those related to electrical products. This article discusses the benefits to manufacturers of this new FDA policy and the associated guidance documents that FDA has made available. PMID:10387610

  13. 21 CFR 814.20 - Application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.20 Application. (a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an...

  14. 21 CFR 814.20 - Application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.20 Application. Link to an... sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place...

  15. Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-12

    The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the penile inflatable implant, a generic type of medical device intended for the treatment of erectile dysfunction. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. PMID:11010632

  16. 75 FR 32476 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... implementing regulations, contained in part 814 (21 CFR part 814), further specifies the contents of a PMA for... approval of a PMA as well as supplements to PMAs. The purpose of this regulation is to establish an... the PMA process, such as section 515(d)(6) of the act. This section provided that PMA supplements...

  17. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and...

  18. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and...

  19. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and...

  20. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and...

  1. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2012-04-01 2012-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  2. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications §...

  3. 21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications §...

  4. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2011-04-01 2011-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  5. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's... 21 Food and Drugs 3 2014-04-01 2014-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  6. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2013-04-01 2013-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  7. 76 FR 20688 - Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... February 25, 1998 (63 FR 9570). This guidance describes the user fees authorized, updates the previous... the guidance entitled ``30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day... of a guidance for industry entitled ``30-Day Notices, 135-Day Premarket Approval (PMA)...

  8. Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-01-14

    The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices. PMID:11010655

  9. Mapping the properties of blue compact dwarf galaxies: integral field spectroscopy with PMAS

    NASA Astrophysics Data System (ADS)

    Cairós, L. M.; Caon, N.; Zurita, C.; Kehrig, C.; Roth, M.; Weilbacher, P.

    2010-09-01

    Context. Blue compact dwarf (BCD) galaxies are low-luminosity, low-metal content dwarf systems undergoing violent bursts of star formation. They present a unique opportunity to probe galaxy formation and evolution and to investigate the process of star formation in a relatively simple scenario. Spectrophotometric studies of BCDs are essential to disentangle and characterize their stellar populations. Aims: We perform integral field spectroscopy of a sample of BCDs with the aim of analyzing their morphology, the spatial distribution of some of their physical properties (excitation, extinction, and electron density) and their relationship with the distribution and evolutionary state of the stellar populations. Methods: Integral field spectroscopy observations of the sample galaxies were carried out with the Potsdam Multi-Aperture Spectrophotometer (PMAS) at the 3.5 m telescope at Calar Alto Observatory. An area 16 arcsec × 16 arcsec in size was mapped with a spatial sampling of 1 arcsec × 1 arcsec. We obtained data in the 3590-6996 Å spectral range, with a linear dispersion of 3.2 Å per pixel. From these data we built two-dimensional maps of the flux of the most prominent emission lines, of two continuum bands, of the most relevant line ratios, and of the gas velocity field. Integrated spectra of the most prominent star-forming regions and of whole objects within the FOV were used to derive their physical parameters and the gas metal abundances. Results: Six galaxies display the same morphology both in emission line and in continuum maps; only in two objects, Mrk 32 and Tololo 1434+032, the distributions of the ionized gas and of the stars differ considerably. In general the different excitation maps for a same object display the same pattern and trace the star-forming regions, as expected for objects ionized by hot stars; only the outer regions of Mrk 32, I Zw 123 and I Zw 159 display higher [S II]/Hα values, suggestive of shocks. Six galaxies display an

  10. Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-09-26

    The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997. PMID:11503643

  11. 21 CFR 807.90 - Format of a premarket notification submission.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Format of a premarket notification submission. 807.90 Section 807.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Radiological Health, be addressed to the Food and Drug Administration, Center for Devices and...

  12. 21 CFR 874.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 874.3 Section 874.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions § 874.3...

  13. 21 CFR 874.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 874.3 Section 874.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions § 874.3...

  14. 21 CFR 874.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 874.3 Section 874.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions § 874.3...

  15. 21 CFR 874.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 874.3 Section 874.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions § 874.3...

  16. 21 CFR 874.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 874.3 Section 874.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions § 874.3...

  17. 21 CFR 886.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 886.3 Section 886.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General Provisions § 886.3 Effective dates...

  18. 21 CFR 892.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 892.3 Section 892.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.3 Effective dates...

  19. 77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    .... FDA published that list in the Federal Register of January 21, 1998 (63 FR 3142). Section 510(m)(2) of...: Powered Patient Transport AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... premarket notification requirements for powered patient transport devices commonly known as...

  20. 21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Action on a premarket notification for a...

  1. 21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

  2. 21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Action on a premarket notification for a...

  3. 21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

  4. 21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

  5. 21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Action on a premarket notification for a...

  6. 21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Action on a premarket notification for a...

  7. 21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

  8. 77 FR 37570 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-22

    ... May 6, 1994 (59 FR 23731), FDA issued a notice of availability of a preamendments class III devices... premarket approval. In the Federal Register of August 4, 2011 (76 FR 47085), FDA published a proposed rule...) Order (April 9, 2009, 74 FR 16214), and any additional information that FDA has encountered....

  9. 76 FR 50663 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... premarket approval. In the Federal Register of May 6, 1994 (59 FR 23731) (the May 6, 1994, notice), FDA... August 25, 2010 (75 FR 52294) (the August 25, 2010, proposed rule), FDA published a proposed rule to... submitted in response to the 515(i) Order, (74 FR 16214, April 9, 2009), and any additional information...

  10. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General...

  11. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General...

  12. 21 CFR 868.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 868.3 Section 868.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.3 Effective dates...

  13. 21 CFR 868.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 868.3 Section 868.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.3 Effective dates...

  14. 21 CFR 868.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 868.3 Section 868.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.3 Effective dates...

  15. 21 CFR 868.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 868.3 Section 868.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.3 Effective dates...

  16. 21 CFR 868.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 868.3 Section 868.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.3 Effective dates...

  17. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... HUMAN SERVICES Food and Drug Administration Medical Devices; Exemption From Premarket Notification... (1976 amendments) (Pub. L. 94-295)), as amended by the Safe Medical Devices Act of 1990 (SMDA) (Pub. L....'' That guidance is available through the Internet at http://www.fda. ]...

  18. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    .../MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm or by sending an email request... HUMAN SERVICES Food and Drug Administration 21 CFR Part 890 Medical Devices; Exemption From Premarket... Part 890 Medical devices, Physical medicine devices. Therefore, under the Federal Food, Drug,...

  19. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ..., metabolism, and excretion), and pharmacodynamics (i.e., all of the effects of the drug on various physiologic... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies; Availability AGENCY: Food and Drug Administration,...

  20. 21 CFR 872.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 872.3 Section 872.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.3 Effective dates...

  1. 21 CFR 872.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 872.3 Section 872.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.3 Effective dates...

  2. 21 CFR 876.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 876.3 Section 876.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES General Provisions § 876.3...

  3. 21 CFR 878.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  4. 21 CFR 878.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  5. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF...

  6. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INITIAL IMPORTERS OF DEVICES Premarket Notification Procedures § 807.87 Information required in a... class III under section 513(b) of the act: (1) Which was introduced or delivered for introduction...

  7. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF...

  8. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3...

  9. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3...

  10. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3...

  11. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3...

  12. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3...

  13. 21 CFR 878.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  14. 21 CFR 878.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  15. 21 CFR 878.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  16. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General...

  17. 21 CFR 892.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 892.3 Section 892.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.3 Effective dates...

  18. 21 CFR 892.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 892.3 Section 892.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.3 Effective dates...

  19. 21 CFR 892.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 892.3 Section 892.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.3 Effective dates...

  20. 21 CFR 892.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 892.3 Section 892.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.3 Effective dates...

  1. 21 CFR 876.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 876.3 Section 876.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES General Provisions § 876.3...

  2. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General...

  3. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General...

  4. 21 CFR 866.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions §...

  5. 21 CFR 866.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions §...

  6. 21 CFR 866.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions §...

  7. 21 CFR 866.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions §...

  8. 21 CFR 866.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions §...

  9. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Food and Drug Administration (FDA) under section 519 of the act. FDA may require the submission of...

  10. Cardiovascular devices; reclassification of nonroller-type cardiopulmonary bypass blood pumps for cardiopulmonary and circulatory bypass; effective date of requirement for premarket approval for nonroller-type cardiopulmonary bypass blood pumps for temporary ventricular support. Final order.

    PubMed

    2015-06-01

    The Food and Drug Administration (FDA) is issuing a final order to reclassify nonroller-type cardiopulmonary bypass blood pump (NRP) devices for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) for NRP devices for temporary ventricular support. FDA is also revising the title and identification of the regulation for NRP devices in this order. PMID:26054096

  11. Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

    PubMed

    2003-04-22

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA). PMID:12708463

  12. Medical Device; exemption from premarket notification; class II devices; pharmacy compounding systems. Final rule.

    PubMed

    2001-03-21

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for pharmacy compounding systems classified within the intravascular administration set, with certain limitations. This rule will exempt from pre market notification pharmacy compounding systems classified within the intravascular administration set and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA). PMID:11706859

  13. EARLY EVALUATION OF NEW HEALTH TECHNOLOGIES: THE CASE FOR PREMARKET STUDIES THAT HARMONIZE REGULATORY AND COVERAGE PERSPECTIVES.

    PubMed

    Levin, Leslie

    2015-01-01

    With an increasing awareness that active engagement between policy decision makers, HTA agencies, regulators and payers with industry in the premarket space is needed, a disruptive comprehensive approach is described which moves the evidentiary process exclusively into this space. Single harmonized studies pre-market to address regulatory and coverage needs and expectations are more likely to be efficient and less costly and position evidence to drive rather than test innovation. An example of such a process through the MaRS EXCITE program in Ontario, Canada, now undergoing proof of concept, is briefly discussed. Other examples of dialogue between decision makers and industry pre-market are provided though these are less robust than a comprehensive evidentiary approach. PMID:26560412

  14. Cardiovascular devices; reclassification of external counter-pulsating devices for treatment of chronic stable angina; effective date of requirement for premarket approval for external counter-pulsating devices for other specified intended uses. Final order.

    PubMed

    2013-12-30

    The Food and Drug Administration (FDA) is issuing a final order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization, which is a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for ECP devices for other intended uses specified in this proposed order. PMID:24383148

  15. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. 170.105 Section 170.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION...

  16. 75 FR 14602 - Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of Comment Period for Future... industry published in the Federal ] Register July 30, 2009, entitled ``Drug-Induced Liver Injury... Liver Diseases (AASLD) and the Pharmaceutical and Research Manufacturers of America, is sponsoring...

  17. Effective date of requirement for premarket approval for transilluminator for breast evaluation and sorbent hemoperfusion system (SHS) devices for the treatment of hepatic coma and metabolic disturbances; reclassification of SHS and devices for the treatment of poisoning and drug overdose. Final order.

    PubMed

    2014-01-17

    The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) for the transilluminator for breast evaluation and sorbent hemoperfusion system (SHS) devices for the treatment of hepatic coma and metabolic disturbances and to reclassify SHS devices for the treatment of poisoning and drug overdose, a preamendments class III device, into class II (special controls). PMID:24443766

  18. Medical devices; exemptions from premarket notification; class II devices. Final rule.

    PubMed

    2001-11-15

    The Food and Drug Administration (FDA) is publishing a final rule exempting from the premarket notification requirements the fluoroscopic compression device, a manual compression device that allows a radiologist to press on the abdomen during a fluoroscopic procedure without exposing his or her hand to the x-ray beam. The device is classified as an accessory to the image-intensified fluoroscopic x-ray system. FDA received a petition requesting an exemption for the F-Spoon device, a type of fluoroscopic manual compression device. FDA is expanding the exemption for this type of generic device to include other fluoroscopic compression devices. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA). PMID:11776279

  19. Medical device; exemption from premarket notification; class II devices; barium enema retention catheters and tips with or without a bag. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-12-01

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for barium enema retention catheters and tips with or without a bag with certain limitations. This rule will exempt from premarket notification barium enema retention catheters and tips with or without a bag. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). PMID:11503724

  20. NEW LIGHT IN STAR-FORMING DWARF GALAXIES: THE PMAS INTEGRAL FIELD VIEW OF THE BLUE COMPACT DWARF GALAXY Mrk 409

    SciTech Connect

    Cairos, Luz M.; Kehrig, Carolina; Weilbacher, Peter; Roth, Martin M.; Caon, Nicola; Zurita, Cristina; Papaderos, Polychronis E-mail: kehrig@aip.d E-mail: mmroth@aip.d E-mail: czurita@iac.e

    2009-12-20

    We present an integral field spectroscopic study of the central 2 x 2 kpc{sup 2} of the blue compact dwarf galaxy Mrk 409, observed with the Potsdam MultiAperture Spectrophotometer (PMAS). This study focuses on the morphology, two-dimensional chemical abundance pattern, excitation properties, and kinematics of the ionized interstellar medium in the starburst component. We also investigate the nature of the extended ring of ionized gas emission surrounding the bright nuclear starburst region of Mrk 409. PMAS spectra of selected regions along the ring, interpreted with evolutionary and population synthesis models, indicate that their ionized emission is mainly due to a young stellar population with a total mass of approx1.5 x 10{sup 6} M{sub sun}, which started forming almost coevally approx10 Myr ago. This stellar component is likely confined to the collisional interface of a spherically expanding, starburst-driven super-bubble with denser, swept-up ambient gas, approx600 pc away from the central starburst nucleus. The spectroscopic properties of the latter imply a large extinction (C{sub Hb}eta>0.9), and the presence of an additional non-thermal ionization source, most likely a low-luminosity active galactic nucleus. Mrk 409 shows a relatively large oxygen abundance (12 + log(O/H) approx 8.4) and no chemical abundance gradients out to R approx 600 pc. The ionized gas kinematics displays an overall regular rotation on a northwest-southeast axis, with a maximum velocity of 60 km s{sup -1}; the total mass inside the star-forming ring is about 1.4 x 10{sup 9} M{sub sun}.

  1. Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports

    PubMed Central

    Chang, Lee; Dhruva, Sanket S; Chu, Janet; Bero, Lisa A

    2015-01-01

    Objective To investigate characteristics of clinical trials and results on safety and effectiveness reported in US Food and Drug Administration (FDA) documents for recently approved high risk cardiovascular devices compared with the characteristics and results reported in peer reviewed publications. Design A search of the publicly available FDA database was performed for all cardiovascular devices that received premarket approval from 1 January 2000 to 31 December 2010. For each study listed in the premarket approval documents, a Medline search was conducted to obtain the corresponding publication. Main outcome measures Clinical trial characteristics, primary endpoints, and safety and efficacy results in the FDA documents and corresponding publications. Results 106 cardiovascular devices received premarket approval from 1 January 2000 to 31 December 2010. FDA premarket approval documents for these devices contained 177 studies, of which 86 (49%) had been published by 1 January 2013. These 86 publications corresponded to 60 distinct devices. The mean time from FDA approval to publication in a peer reviewed journal was 6.5 months (range −4.8-7.5 years). In 22 (26%) of the 86 compared studies the number of participants enrolled in the study differed in the FDA summary and the corresponding publications. Of 152 primary endpoints identified in the FDA documents, in the corresponding publications three (2%) were labeled as secondary, 43 (28%) were unlabeled, and 15 (10%) were not found. Among the primary results, 69 (45%) were identical, 35 (23%) were similar, 17 (11%) were substantially different, and 31 (20%) could not be compared. Conclusions Many clinical trials for high risk cardiovascular devices approved by the FDA remain unpublished. Even when trials are published, the study population, primary endpoints, and results can differ substantially from data submitted to the FDA. PMID:26063311

  2. An evaluation of conventional culture, invA PCR, and the real-time PCR iQ-Check kit as detection tools for Salmonella in naturally contaminated premarket and retail turkey.

    PubMed

    Nde, Chantal W; Fakhr, Mohamed K; Doetkott, Curt; Logue, Catherine M

    2008-02-01

    This study was aimed at comparing the ability of conventional culture, the iQ-Check real-time PCR kit, and invA PCR to detect Salmonella in naturally contaminated premarket and retail turkey parts. Premarket (n = 120) turkey parts collected from a commercial turkey processing plant, and retail turkey parts (n = 138) were examined. Both PCR methods detected a significantly greater (P < 0.05) number of positive samples when compared with the conventional culture method for the premarket turkey parts. The indices of total agreement between the conventional culture method and the iQ-Check kit for the premarket and retail parts were 79.2% (95% CI: 70.8, 86) and 90.6% (95% CI: 84.4, 94.9), respectively. When the conventional culture method was compared with invA PCR for Salmonella detection in the premarket and retail parts, the indices of total agreement were 75.8% (95% CI: 67.2, 83.2) and 84.1% (95% CI: 76.9, 89.7), respectively. The rates of false positives (premarket: 31.9%, retail: 9.7%) and false negatives (premarket: 5.9%, retail: 9.7%) were determined between the culture method and the iQ-Check kit. When invA PCR was compared with the culture method, the rates of false positives (premarket: 37.7%, retail: 11.1%) and false negatives (premarket: 5.9%, retail: 18.3%) were obtained. The higher total agreement and the lower rates of both false positives and false negatives for the iQ-Check kit compared with invA PCR for both premarket and retail turkey parts corroborates the use of the iQ-Check kit as a screening tool for Salmonella in poultry meat. PMID:18326192

  3. 76 FR 60055 - Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... tobacco product to meet with the Office of Science at the Center for Tobacco Products (CTP) to discuss... for a meeting should be sent in writing to the Director of CTP's Office of Science and should include... Meeting with CTP's 18 1 18 4 72 Office of Science to discuss Investigational Plan 21 CFR 25.40...

  4. Cardiovascular devices; reclassification of intra-aortic balloon and control systems for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure; effective date of requirement for premarket approval for intra-aortic balloon and control systems for septic shock or pulsatile flow generation. Final order.

    PubMed

    2013-12-30

    The Food and Drug Administration (FDA) is issuing a final order to reclassify intra-aortic balloon and control system (IABP) devices when indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for IABPs when indicated for septic shock or pulsatile flow generation. PMID:24383147

  5. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD...

  6. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  7. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  8. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  9. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  10. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  11. Information Regarding the OraQuick In-Home HIV Test

    MedlinePlus

    ... test? Information on the OraQuick In-Home HIV Test can be found on FDA’s website . Additionally, information can be obtained from the manufacturer, OraSure Technologies. back to top More in Premarket Approvals (PMAs) ...

  12. Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis

    PubMed Central

    Iijima, Kazuo; Umezu, Mitsuo; Iwasaki, Kiyotaka

    2016-01-01

    Background Clinical studies for assessing the effectiveness and safety in a premarketing setting are conducted under time and cost constraints. In recent years, postmarketing data analysis has been given more attention. However, to our knowledge, no studies have compared the effectiveness and the safety between the pre- and postmarketing settings. In this study, we aimed to investigate the importance of the postmarketing data analysis using clinical data. Methods and Findings Studies on capsule endoscopy with rich clinical data in both pre- and postmarketing settings were selected for the analysis. For effectiveness, clinical studies published before October 10, 2015 comparing capsule endoscopy and conventional flexible endoscopy measuring the detection ratio of obscure gastrointestinal bleeding were selected (premarketing: 4 studies and postmarketing: 8 studies) from PubMed (MEDLINE), Cochrane Library, EMBASE and Web of Science. Among the 12 studies, 5 were blinded and 7 were non-blinded. A time series meta-analysis was conducted. Effectiveness (odds ratio) decreased in the postmarketing setting (premarketing: 5.19 [95% confidence interval: 3.07–8.76] vs. postmarketing: 1.48 [0.81–2.69]). The change in odds ratio was caused by the increase in the detection ratio with flexible endoscopy as the control group. The efficacy of capsule endoscopy did not change between pre- and postmarketing settings. Heterogeneity (I2) increased in the postmarketing setting because of one study. For safety, in terms of endoscope retention in the body, data from the approval summary and adverse event reports were analyzed. The incidence of retention decreased in the postmarketing setting (premarketing: 0.75% vs postmarketing: 0.095%). The introduction of the new patency capsule for checking the patency of the digestive tract might contribute to the decrease. Conclusions Effectiveness and safety could change in the postmarketing setting. Therefore, time series meta-analyses could be

  13. 78 FR 44130 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... application (PMA), Product Development Protocol, Humanitarian Device Exemption (HDE), Petition for Evaluation... the Food and Drug Administration Modernization Act (FDAMA) (Pub. L. 105-115) amended section 514...

  14. The application of post-market monitoring to novel foods.

    PubMed

    Hepburn, P; Howlett, J; Boeing, H; Cockburn, A; Constable, A; Davi, A; de Jong, N; Moseley, B; Oberdörfer, R; Robertson, C; Wal, J M; Samuels, F

    2008-01-01

    The role of post-market monitoring (PMM) in the safety assessment of novel foods is critically discussed in order to derive guidelines as to in which situations the application of PMM might be warranted. Available data sources on food consumption and health status, and the methodologies for generating such data are reviewed. The paper suggests improvements to make them more applicable for PMM purposes. It is concluded that any PMM programme must be a hypothesis-driven scientific exercise. PMM can have a role as a complement to, but not as a replacement for, a comprehensive pre-market safety assessment. Its use may be appropriate to confirm that product use is as predicted in the pre-market assessment; to provide reassurance that effects observed in the pre-market assessment occur with no greater frequency or intensity in the post-market phase than anticipated; and to investigate the significance of any adverse effects reported by consumers after market-launch. However PMM is insufficiently powerful to test the hypothesis that any effects seen in the pre-market assessment are absent in the post-market phase. Current methodologies place limitations on what PMM can achieve. PMM should only be used when triggered by or when the focus is on specific evidence-based questions. PMID:17950974

  15. Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems.

    PubMed

    Walter, Jessica R; Hayman, Emily; Tsai, Shelun; Ghobadi, Comeron W; Xu, Shuai

    2016-06-01

    Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation. The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015. Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days). Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials. Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices. PMID:27159747

  16. 21 CFR 884.2685 - Fetal scalp clip electrode and applicator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... electrode applicator. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the... shall have an approved PMA or a declared completed PDP in effect before being placed in...

  17. 21 CFR 884.2685 - Fetal scalp clip electrode and applicator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... electrode applicator. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the... shall have an approved PMA or a declared completed PDP in effect before being placed in...

  18. 78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-21

    ...)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice... announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b... of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period...

  19. 78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ...(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA...) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on.... Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these...

  20. 77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-16

    ...)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice... announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b... of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period...

  1. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... constitute a clearly unwarranted invasion of personal privacy under § 20.63; provided, however, that except... under § 20.61, FDA will disclose to a patient who requests a report all the information in the report concerning that patient. (4) A list of components previously disclosed to the public, as such disclosure...

  2. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... constitute a clearly unwarranted invasion of personal privacy under § 20.63; provided, however, that except... under § 20.61, FDA will disclose to a patient who requests a report all the information in the report concerning that patient. (4) A list of components previously disclosed to the public, as such disclosure...

  3. The benefits of the 3T3 NRU test in the safety assessment of cosmetics: long-term experience from pre-marketing testing in the Czech Republic.

    PubMed

    Jírová, D; Kejlová, K; Brabec, M; Bendová, H; Kolárová, H

    2003-01-01

    We have introduced the 3T3 NRU cytotoxicity test for methodological, economical and ethical reasons as a regular part of tier pre-marketing testing to assess local tolerance of raw materials for cosmetics, household chemicals and final cosmetic products. Using the 3T3 cell line according to the standard INVITTOX protocol No.64 (NRU Assay) the borderline concentration, relevant to the highest tolerated dose, is determined for each material. The toxic effect is reached at different concentration levels specific for individual cosmetics categories, depending on their chemical characteristics. Typical ranges of cytotoxicity for specific categories of cosmetics were established after testing of hundreds of materials. The range lies between 1 microg/ml (anti-dandruff shampoos), up to 2000 microg/ml (toothpastes and mouthwashes). The 3T3 NRU cytotoxicity test is a sensitive tool able to identify more aggressive products, that are also more likely to evoke irritation in human skin. It was even possible to detect protective effects of one natural herbal ingredient. The comparative study of cytotoxicity test results and human patch test results from a group of essential oils is presented. Cytotoxicity tests represent a highly ethical approach for estimation of irritancy. On the basis of in vitro test results suggesting low risk we can proceed to confirmatory tests in human volunteers. PMID:14599479

  4. High-density power management architecture for portable applications

    NASA Astrophysics Data System (ADS)

    Ahsanuzzaman, S. M.

    This thesis introduces a power management architecture (PMA) and its on-chip implementation, designed for battery-powered portable applications. Compared to conventional two-stage PMA architectures, consisting of a front-end inductive converter followed by a set of point-of-load (PoL) buck converters, the presented PMA has improved power density. The new architecture, named MSC-DB, is based on a hybrid converter topology that combines a fixed ratio multi-output switched capacitor converter (MSC) and a set of differential-input buck (DB) converters, to achieve low volume and high power processing efficiency. The front-end switched capacitor stage has a higher power density than the conventionally used inductive converters. The downstream differential-input buck converters enable tight output voltage regulation, and allow for a drastic reduction of output filter inductors without the need for increasing switching frequency, hence limiting switching losses and improving the efficiency of the system. Furthermore, the new PMA provides battery cells balancing feature, not existing in conventional systems. The PMA architecture is implemented both as a discrete prototype and as an application-specific integrated circuit (IC) module. The on-chip implemented architecture is fabricated in a standard 0.13microm CMOS process and operates at 9.3 MHz switching frequency. Experimental comparisons with a conventional two-cell battery input architecture, providing 15 W of total power in three different voltage outputs, demonstrate up to a 50% reduction in the inductances of the downstream converter stages and up to a 53% reduction in losses, equivalent to the improvement of the power processing efficiency of a 12%. Moreover, the fabricated IC module is co-packaged with low-profile thin-film inductors, to demonstrate the effectiveness of the introduced architecture in reducing the volume of PMAs for portable applications and possibly providing complete on-chip implementation of PMAs

  5. 77 FR 45359 - Medical Device User Fee Rates for Fiscal Year 2013

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... standard fee for a premarket application (a premarket application is a premarket approval application (PMA... (a PMA submitted under Base Fee Adjusted as Specified $248,000 $62,000 section 515(c)(1) of the FD&C... also qualify for a waiver of the fee for your first premarket application (PMA, PDP, or BLA)...

  6. 75 FR 81282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ... premarket approval application (PMA)) or reclassify to class II (subject to premarket notification (510(k... PMA supplement for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular. The RX...

  7. 76 FR 43693 - Standard Operating Procedure for “Notice to Industry” Letters

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... Investigational Device Exemption (IDE) or premarket submission that needs to be disseminated in a timely manner... has changed its expectations for data submitted as part of an IDE or premarket application on...

  8. 21 CFR 814.37 - PMA amendments and resubmitted PMA's.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814... to amend a PMA or PMA supplement with any information regarding the device that is necessary for...

  9. 21 CFR 814.37 - PMA amendments and resubmitted PMA's.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814... to amend a PMA or PMA supplement with any information regarding the device that is necessary for...

  10. Guidance for Industry: Preparation of Premarket Submissions ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... 确定这些数据的方法。如果难以取得分子量,申请人应提供聚合体的其他属性; 这些属性应为分子量的应变量,例如固有粘度或相对粘度、或熔体流动指数 ...

  11. Comparison between small radiation therapy electron beams collimated by Cerrobend and tubular applicators.

    PubMed

    Di Venanzio, Cristina; Marinelli, Marco; Tonnetti, Alessia; Verona-Rinati, Gianluca; Bagalà, Paolo; Falco, Maria Daniela; Guerra, Antonio Stefano; Pimpinella, Maria

    2015-01-01

    The purpose of this study was to compare the dosimetric properties of small field electron beams shaped by circular Cerrobend blocks and stainless steel tubular applicators. Percentage depth dose curves, beam profiles, and output factors of small-size circular fields from 2 to 5 cm diameter, obtained either by tubular applicators and Cerrobend blocks, were measured for 6, 10, and 15 MeV electron beam energies. All measurements were performed using a PTW microDiamond 60019 premarket prototype. An overall similar behavior between the two collimating systems can be observed in terms of PDD and beam profiles. However, Cerrobend collimators produce a higher bremsstrahlung background under irradiation with high-energy electrons. In such irradiation condition, larger output factors are observed for tubular applicators. Similar dosimetric properties are observed using circular Cerrobend blocks and stainless steel tubular applicators at lower beam energies. However, Cerrobend collimators allow the delivery of specific beam shapes, conformed to the target area. On the other hand, in high-energy irradiation conditions, tubular applicators produce a lower bremsstrahlung contribution, leading to lower doses outside the target volume. In addition, the higher output factors observed at high energies for tubular applicators lead to reduced treatment times. PMID:25679175

  12. 75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... premarket approval application (PMA) for SOLESTA, sponsored by Oceana Therapeutics, Inc. SOLESTA is... PMA for the LAP-BAND Adjustable Gastric Banding System, sponsored by Allergan. The sponsor...

  13. 21 CFR 814.104 - Original applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.104 Original... determination made by FDA's Office of Orphan Products Development (in accordance with § 814.102) that the device qualifies as a HUD; (2) An explanation of why the device would not be available unless an HDE were...

  14. 21 CFR 814.104 - Original applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.104 Original... Development (in accordance with § 814.102) that the device qualifies as a HUD; (2) An explanation of why the device would not be available unless an HDE were granted and a statement that no comparable device...

  15. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS... Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... included in IDE and PMA applications, focusing on critical elements of safety and effectiveness...

  16. Cardiovascular safety profile of dapoxetine during the premarketing evaluation.

    PubMed

    Kowey, Peter R; Mudumbi, Ramagopal V; Aquilina, Joseph W; DiBattiste, Peter M

    2011-01-01

    The cardiovascular safety profile of dapoxetine, a novel selective serotonin reuptake inhibitor (SSRI) developed as an on-demand oral treatment for premature ejaculation (PE) in men, is evaluated. The cardiovascular assessment of dapoxetine was conducted throughout all stages of drug development, with findings from preclinical safety pharmacology studies, phase I clinical pharmacology studies investigating the effect of dapoxetine on QT/corrected QT (QTc) intervals in healthy men, and phase III, randomized, placebo-controlled studies evaluating the safety (and efficacy) of the drug. Preclinical safety pharmacology studies did not suggest an adverse electrophysiologic or hemodynamic effect with concentrations of dapoxetine up to 2-fold greater than recommended doses. Phase I clinical pharmacology studies demonstrated that dapoxetine did not prolong the QT/QTc interval and had neither clinically significant electrocardiographic effects nor evidence of delayed repolarization or conduction effects, with dosing up to 4-fold greater than the maximum recommended dosage. Phase III clinical studies of dapoxetine in men with PE indicated that dapoxetine was generally safe and well tolerated with the dosing regimens used (30 mg and 60 mg as required). Events of syncope were reported during the clinical development program, with the majority occurring during study visits (on site) on day 1 following administration of the first dose when various procedures (e.g. orthostatic maneuvers, venipunctures) were performed, suggesting that the procedures contributed to the incidence of syncope. This was consistent with previous reports showing that these and similar factors contribute to or trigger vasovagal syncope. Findings of the dapoxetine development program demonstrate that dapoxetine is associated with vasovagal-mediated (neurocardiogenic) syncope. No other associated significant cardiovascular adverse events were identified. PMID:21410293

  17. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... language, it shall be accompanied by an accurate and complete English translation; and (5) The signature of... supplement; (4) The history of use or other evidence of safety establishing that the dietary ingredient,...

  18. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation; and (5) The signature of the person designated by the manufacturer or... supplement, the ordinary conditions of use of the supplement; (4) The history of use or other evidence...

  19. 21 CFR 190.6 - Requirement for premarket notification.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation; and (5) The signature of the person designated by the manufacturer or... supplement, the ordinary conditions of use of the supplement; (4) The history of use or other evidence...

  20. Premarket Safety and Efficacy Studies for ADHD Medications in Children

    PubMed Central

    Bourgeois, Florence T.; Kim, Jeong Min; Mandl, Kenneth D.

    2014-01-01

    Background Attention-deficit hyperactivity disorder (ADHD) is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing. Methods We identified all ADHD medications approved by the Food and Drug Administration (FDA) and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug’s clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials. Results A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419). Eleven drugs (55%) were approved after <100 participants were studied and 14 (70%) after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9), with 5 (38%) drugs approved after participants were studied <4 weeks and 10 (77%) after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed. Conclusions Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved. PMID:25007171

  1. 21 CFR 807.85 - Exemption from premarket notification.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... a patient named in the order of the physician or dentist (or other specially qualified person); or (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other...

  2. 21 CFR 807.85 - Exemption from premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... a patient named in the order of the physician or dentist (or other specially qualified person); or (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other...

  3. [Literature review on premarketing and postmarketing evidence of xiyanping injection].

    PubMed

    Wang, Zhi-Fei; Chen, Xiao; Zhang, Wen; Xie, Yan-Ming

    2014-09-01

    This article systematically summarizes the non-clinical safety studies, pharmacological studies and postmarketing safety studies of Xiyanping injection based on literature. These studies include acute toxicity test, long-term toxicity test, reproductive toxicity test, active and passive anaphylaxis test, curative mechanism study, clinical trials of effectiveness, active surveillance, security analysis of passive monitoring data, the real world analysis of hospital information system (HIS) data, literature analysis, etcetera This article also analysis the relationship of the different evidence, summarizes the strategy of the researches, in order to make it to be a reference for making a systemic research program of traditional Chinese medicine injection. PMID:25532411

  4. Premarketing surveillance of ibuprofen suppositories in febrile children.

    PubMed

    Hadas, Dan; Youngster, Ilan; Cohen, Avner; Leibovitch, Eugene; Shavit, Itai; Erez, Ilan; Uziel, Yosef; Berkovitch, Matitiahu

    2011-03-01

    In many countries, ibuprofen is available only in oral formulations. The authors aimed to investigate parental satisfaction and possible adverse reactions among children receiving newly marketed ibuprofen suppositories, prior to their arrival at the pharmaceutical points of distribution. Children needing antipyretic medication were recruited from 11 pediatric wards and clinics in Israel. Each patient received ibuprofen suppositories (5-10 mg/kg/dose) after completing a data collection form. After 3 to 7 days of treatment, information regarding parent satisfaction, possible adverse reactions, and concomitant use of drugs was obtained. Overall, 490 children completed the study. Parents' satisfaction was high (4.5 ± 0.47 on a scale of 1-5), and 92.2% reported that they would use the medication in the future. Adverse reactions were reported in 8 patients (1.63%, 95% confidence interval = 1.77-3.25), the most common being diarrhea. Rectal administration of ibuprofen suppositories is well tolerated and overall satisfaction and the repeated expected use were high. PMID:21224250

  5. 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-07

    ... Federal Register on April 27, 2009, (74 FR 19094), FDA announced the availability of the draft guidance of... application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA...) or a PMA application for the injector alone. For a combination product that includes the...

  6. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

    ... guidance practices regulation. FDA withdrew the 1994 draft on January 5, 2005 (70 FR 824) and is now... Staff; Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.'' This draft guidance...

  7. 21 CFR 814.37 - PMA amendments and resubmitted PMA's.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false PMA amendments and resubmitted PMA's. 814.37... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.37 PMA amendments and resubmitted PMA's. (a) An applicant may amend a pending PMA or PMA...

  8. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false PMA supplements. 814.39 Section 814.39 Food and... PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. (a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by...

  9. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to... or effectiveness of the device for which the applicant has an approved PMA, unless the change is of...

  10. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. (a... before making a change affecting the safety or effectiveness of the device for which the applicant has...

  11. 21 CFR 814.37 - PMA amendments and resubmitted PMA's.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814... information regarding the device that is necessary for FDA or the appropriate advisory committee to complete... applicant to amend a PMA or PMA supplement with any information regarding the device that is necessary...

  12. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. (a... before making a change affecting the safety or effectiveness of the device for which the applicant has...

  13. Properties of the ionized gas in HH202 - I. Results from integral field spectroscopy with PMAS

    NASA Astrophysics Data System (ADS)

    Mesa-Delgado, A.; López-Martín, L.; Esteban, C.; García-Rojas, J.; Luridiana, V.

    2009-04-01

    We present results from integral field spectroscopy with the Potsdam Multi-Aperture Spectrograph of the head of the Herbig-Haro (HH) object HH202 with a spatial sampling of 1 × 1arcsec2. We have obtained maps of different emission lines, physical conditions - such as electron temperature and density - and ionic abundances from recombination and collisionally excited lines. We present the first map of the Balmer temperature and of the temperature fluctuation parameter, t2. We have calculated the t2 in the plane of the sky, which is substantially smaller than that determined along the line of sight. We have mapped the abundance discrepancy factor (ADF) of O2+, ADF(O2+), finding its maximum value at the HH202-S position. We have explored the relations between the ADF(O2+) and the electron density, the Balmer and [OIII] temperatures, the ionization degree as well as the t2 parameter. We do not find clear correlations between these properties and the results seem to support that the ADF and t2 are independent phenomena. We have found a weak negative correlation between the O2+ abundance determined from recombination lines and the temperature, which is the expected behaviour in an ionized nebula, hence it seems that there is no evidence for the presence of supermetal-rich droplets in HII regions. Based on observations collected at the Centro Astronómico Hispano Alemán (CAHA) at Calar Alto, operated jointly by the Max-Planck Institut für Astronomie and the Instituto de Astrofísica de Andalucía (CSIC). E-mail: amd@iac.es

  14. Crowded Field 3D Spectroscopy -- The Next Step: First Light for PMAS

    NASA Astrophysics Data System (ADS)

    Roth, Martin M.; Becker, Thomas; Böhm, Petra; Kelz, Andreas

    8-10m class telescopes, combined with highly efficient instrumentation and superb seeing conditions, have set new frontiers not only for the observation of faint galaxies in the distant universe, but also for the spectroscopy of stellar populations in nearby galaxies, such as A- and B-type supergiants, luminous blue variables (LBVs), planetary nebulae (PNe), HII regions etc., which have been hardly observable with previous techniques. The detailed study of these individual objects provides information for star formation and evolution, stellar populations, chemical abundances, and hence important constraints for galactic evolution and cosmology (see also Prieto, these proceedings).

  15. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ... premarket approval (PMA) application in that the applicant must demonstrate a reasonable assurance of safety, but in an HDE application, the applicant seeks an exemption from the PMA requirement to demonstrate...

  16. 21 CFR 876.3350 - Penile inflatable implant.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is... distribution before May 28, 1976. Any other penile inflatable implant shall have an approved PMA or a...

  17. 21 CFR 884.5380 - Contraceptive tubal occlusion device (TOD) and introducer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with... May 28, 1976. Any other TOD and introducer shall have an approved PMA or a declared completed PDP...

  18. 76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ..., including CTR, CTT, and Low Glucose Suspend systems. On June 22, 2011 (76 FR 36542), FDA announced the... Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' This... and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval...

  19. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (premarket approval). (c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and... testicular prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed...

  20. 21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be... nerve stimulator shall have an approved PMA or a declared completed PDP in effect before being placed...

  1. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is.... Any other implanted intracerebral/subcortical stimulator for pain relief shall have an approved PMA...

  2. 21 CFR 882.5830 - Implanted diaphragmatic/phrenic nerve stimulator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be... nerve stimulator shall have an approved PMA or a declared completed PDP in effect before being placed...

  3. 21 CFR 884.5380 - Contraceptive tubal occlusion device (TOD) and introducer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with... May 28, 1976. Any other TOD and introducer shall have an approved PMA or a declared completed PDP...

  4. 21 CFR 814.37 - PMA amendments and resubmitted PMA's.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false PMA amendments and resubmitted PMA's. 814.37... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.37 PMA amendments and resubmitted PMA's. Link to an amendment published at 75 FR 16351, Apr. 1,...

  5. 21 CFR 884.1600 - Transabdominal amnioscope (fetoscope) and accessories.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is... transabdominal amnioscope (fetoscope) and accessories shall have an approved PMA or a declared completed PDP...

  6. 21 CFR 884.1600 - Transabdominal amnioscope (fetoscope) and accessories.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is... transabdominal amnioscope (fetoscope) and accessories shall have an approved PMA or a declared completed PDP...

  7. 21 CFR 814.39 - PMA supplements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false PMA supplements. 814.39 Section 814.39 Food and... PREMARKET APPROVAL OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to an amendment published at 75 FR 16351, Apr. 1, 2010. (a) After FDA's approval of a PMA, an...

  8. 78 FR 12664 - Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... FR 25692, May 9, 1997). Many of the principles underlying GCP have already been incorporated in FDA's... guidance for industry in 1997 (62 FR 25692, May 9, 1997). Proposed Sec. 812.28(a)(2) states the second... (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA)...

  9. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (premarket approval). (c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and... testicular prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed...

  10. 21 CFR 870.3925 - Replacement heart valve.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... materials. (b) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of... have an approved PMA or a declared completed PDP in effect before being placed in...

  11. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is.... Any other implanted intracerebral/subcortical stimulator for pain relief shall have an approved PMA...

  12. 21 CFR 870.3925 - Replacement heart valve.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... materials. (b) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of... have an approved PMA or a declared completed PDP in effect before being placed in...

  13. 21 CFR 876.3350 - Penile inflatable implant.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    .... Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is... distribution before May 28, 1976. Any other penile inflatable implant shall have an approved PMA or a...

  14. Biomimetic actuators in prosthetic and rehabilitation applications.

    PubMed

    Caldwell, D G; Tsagarakis, N

    2002-01-01

    Where humans and mechanical systems operate in close proximity there is a need to provide drive systems that combine the positive attributes of conventional actuator design with a 'softer' safer interaction capacity. This is achieved by natural muscle, and engineering emulation of this functionality could have a significant benefits in many areas, but particularly the medical domain. This work will study the use of compliance regulated and controlled pairs of antagonistic pneumatic Muscle Actuators (pMAs) in two medical scenarios; i) The construction of dexterous prosthetic hands having a high power and low mass potential, ii) The construction of a power assist device that can be used to augment the strength of those suffering from degenerative muscle wasting diseases. PMID:12082215

  15. Creation of an iOS and Android Mobile Application for Inferior Vena Cava (IVC) Filters: A Powerful Tool to Optimize Care of Patients with IVC Filters.

    PubMed

    Deso, Steven E; Idakoji, Ibrahim A; Muelly, Michael C; Kuo, William T

    2016-06-01

    Owing to a myriad of inferior vena cava (IVC) filter types and their potential complications, rapid and correct identification may be challenging when encountered on routine imaging. The authors aimed to develop an interactive mobile application that allows recognition of all IVC filters and related complications, to optimize the care of patients with indwelling IVC filters. The FDA Premarket Notification Database was queried from 1980 to 2014 to identify all IVC filter types in the United States. An electronic search was then performed on MEDLINE and the FDA MAUDE database to identify all reported complications associated with each device. High-resolution photos were taken of each filter type and corresponding computed tomographic and fluoroscopic images were obtained from an institutional review board-approved IVC filter registry. A wireframe and storyboard were created, and software was developed using HTML5/CSS compliant code. The software was deployed using PhoneGap (Adobe, San Jose, CA), and the prototype was tested and refined. Twenty-three IVC filter types were identified for inclusion. Safety data from FDA MAUDE and 72 relevant peer-reviewed studies were acquired, and complication rates for each filter type were highlighted in the application. Digital photos, fluoroscopic images, and CT DICOM files were seamlessly incorporated. All data were succinctly organized electronically, and the software was successfully deployed into Android (Google, Mountain View, CA) and iOS (Apple, Cupertino, CA) platforms. A powerful electronic mobile application was successfully created to allow rapid identification of all IVC filter types and related complications. This application may be used to optimize the care of patients with IVC filters. PMID:27247483

  16. 21 CFR 872.3930 - Bone grafting material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared...

  17. 78 FR 76150 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-16

    ... Act. In the Federal Register of February 19, 2013, (78 FR 11654), FDA published a 60-day notice.... Any premarket approval application (PMA) or supplement to a PMA submitted under section 515 of the...

  18. 77 FR 16038 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS) sponsored..., the committee will discuss, make recommendations and vote on information related to the PMA for...

  19. 21 CFR 872.3930 - Bone grafting material.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared...

  20. 21 CFR 807.3 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... code means the code used by FDA to identify the generic category of a device. (l) Representative... submission, such as a Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); New...

  1. 21 CFR 814.15 - Research conducted outside the United States.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.15 Research... foreign data are applicable to the U.S. population and U.S. medical practice; (2) The studies have...

  2. 21 CFR 814.15 - Research conducted outside the United States.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.15 Research... foreign data are applicable to the U.S. population and U.S. medical practice; (2) The studies have...

  3. 21 CFR 814.15 - Research conducted outside the United States.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.15 Research... foreign data are applicable to the U.S. population and U.S. medical practice; (2) The studies have...

  4. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... clarify the criteria for accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements..., suite 200N, Rockville, MD 20852-1448, 301-827-6210. I. Background The PMA regulation (21 CFR...

  5. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... Federal Register of July 31, 2012 (77 FR 45357), FDA announced the availability of the draft guidance... accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements reviewed in the Center for...

  6. 78 FR 20268 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... transilluminator for breast evaluation (76 FR 48062, August 8, 2011; 77 FR 9610, February 17, 2012; 77 FR 39953, July 6, 2012; 75 FR 52294, August 25, 2010). FDA is issuing this proposed administrative order to... 5, 2013 (77 FR 71195, November 29, 2012). Because of the level of interest in the classification...

  7. 21 CFR 807.90 - Format of a premarket notification submission.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Radiological Health, be addressed to the Food and Drug Administration, Center for Devices and Radiological....90 Section 807.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Document Control Center (HFM-99), Center for Biologics Evaluation and Research,......

  8. 21 CFR 807.90 - Format of a premarket notification submission.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Radiological Health, be addressed to the Food and Drug Administration, Center for Devices and Radiological....90 Section 807.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Document Control Center (HFM-99), Center for Biologics Evaluation and Research,......

  9. 21 CFR 807.90 - Format of a premarket notification submission.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Radiological Health, be addressed to the Food and Drug Administration, Center for Devices and Radiological....90 Section 807.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Document Control Center (HFM-99), Center for Biologics Evaluation and Research,......

  10. 21 CFR 860.132 - Procedures when the Commissioner initiates a performance standard or premarket approval...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE CLASSIFICATION PROCEDURES Reclassification § 860.132 Procedures... the classification of a device based upon new information relevant to its classification when the Commissioner initiates a proceeding either to develop a performance standard for the device if in class II,...

  11. 21 CFR 860.132 - Procedures when the Commissioner initiates a performance standard or premarket approval...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE CLASSIFICATION PROCEDURES Reclassification § 860.132 Procedures... the classification of a device based upon new information relevant to its classification when the Commissioner initiates a proceeding either to develop a performance standard for the device if in class II,...

  12. 78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ..., 1998 (63 FR 3142). Section 510(m)(2) of the FD&C Act provides that FDA may exempt a device from..., p. 3.) In the Federal Register of June 1, 2012 (77 FR 32642), FDA published a notice announcing that... against the criteria laid out in the Class II 510(k) Exemption Guidance and in 63 FR 3142, and agrees...

  13. 76 FR 53851 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... a proposed rule that appeared in the Federal Register of August 8, 2011 (76 FR 48058). The document..., Silver Spring, MD 20993-0002, 301-796-6216. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-19959, appearing... read ``1. Geiger, D.R., ``FY 2003 and 2004 Unit Costs for the Process of Medical Device...

  14. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... that has undergone a significant change or modification that could significantly affect the safety or... considered what consequences and effects the change or modification or new use might have on the safety and... types of safety and effectiveness problems associated with the type of devices being compared and...

  15. 75 FR 54154 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ..., 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register. Instead, the agency... (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will...

  16. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ... withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order... under Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the...-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by...

  17. 75 FR 36099 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal.... 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a...

  18. 75 FR 72829 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the... a PMA will continue to include a notice of opportunity to request review of the order under...

  19. 76 FR 17136 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published... PMA approvals and denials in the Federal Register. Instead, the Agency now posts this information on... approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity...

  20. 77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-04

    ..., or withdrawing approval of a PMA will continue to include a notice of opportunity to request review... of an FDA action under Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA... cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may...

  1. 75 FR 52294 - Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-25

    ... response to the 515(i) order (74 FR 16214, April 9, 2009) and any additional information that FDA has... dates: Cardiovascular devices, 21 CFR part 870 (44 FR 13284, March 9, 1979; 45 FR 7904, February 5, 1980; and 52 FR 17736, May 11, 1987); classification of female condoms (64 FR 31164, June 10, 1999; and...

  2. 75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

    ... In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the.... 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a...

  3. 78 FR 17890 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ...-month period has expired (see 68 FR 61342, October 28, 2003). If a PMA is not filed for such devices... order (74 FR 16214, April 9, 2009) requiring manufacturers to submit information about a number of... thus, AEDs were classified as class III devices. On October 28, 2003 (68 FR 61342), FDA published...

  4. 76 FR 44872 - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ... the 515(i) Order that published in the Federal Register of April 9, 2009 (74 FR 16214), and any... published in the Federal Register on the following dates: March 9, 1979 (44 FR 13373); February 5, 1980 (45 FR 7907); and May 11, 1987 (52 FR 17736). IV. Device Subject to This Proposal--Implantable...

  5. 76 FR 47085 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-04

    ... 515(i) Order (74 FR 16214, April 9, 2009), and any additional information that FDA has encountered... found in the following proposed and final rules and notices published in the Federal Register: 44 FR 13382, March 9, 1979; 45 FR 7907-7971, February 5, 1980; and 52 FR 17736, May 11, 1987. IV....

  6. 78 FR 4094 - Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-18

    ... 1987, the 30-month period has expired (52 FR 33686 at 33706, September 4, 1987). Therefore, if the... classification of these devices along with information submitted in response to the 515(i) Order (74 FR 16214... proposed and final rules and notices published in the Federal Register: 47 FR 29052 (July 2, 1982), 52...

  7. 78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ... withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order... under Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the...-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by...

  8. 76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-02

    .... Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that amended 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in..., denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to...

  9. 77 FR 35690 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ..., or withdrawing approval of a PMA will continue to include a notice of opportunity to request review... of an FDA action under Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA... cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may...

  10. 77 FR 2071 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-13

    ..., or withdrawing approval of a PMA will continue to include a notice of opportunity to request review... of an FDA action under Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA... cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may...

  11. 78 FR 5816 - Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-28

    ... effects in specific subgroups (i.e., use in study enrichment strategies). On February 18, 2011 (76 FR 9583... how variations in the human genome, specifically DNA sequence variants, could affect a drug's..., specifically DNA sequence variants, could affect a drug's pharmacokinetics, pharmacodynamics, efficacy,...

  12. 78 FR 52773 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... invites comments on the procedure by which a manufacturer or distributor of dietary supplements or of a... dietary supplements or of a new dietary ingredient is to submit to us (as delegate for the Secretary of... ingredient, to submit to the Office of Nutrition, Labeling, and Dietary Supplements (ONLDS) notification...

  13. 76 FR 32214 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ... notice solicits comments on the procedure by which a manufacturer or distributor of dietary supplements... dietary supplements or of a new dietary ingredient is to submit to FDA (as delegate for the Secretary of... ingredient, to submit to the Office of Nutrition, Labeling, and Dietary Supplements notification of the...

  14. 76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-04

    ... INFORMATION: I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final.... P070015 (S54) FDA-2011-M-0431. Abbott Vascular....... Xience nano everolimus-eluting May 24,...

  15. 78 FR 69693 - Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... transplantation. The guidance provides detailed information on the types of studies FDA recommends for validation... information on the types of studies FDA recommends for validation of HLA test kits submitted as 510(k)s. The... designing and conducting studies for validation of nucleic acid-based HLA test kits and preparing a...

  16. Corneal ulcer and adverse reaction rates in premarket contact lens studies.

    PubMed

    MacRae, S; Herman, C; Stulting, R D; Lippman, R; Whipple, D; Cohen, E; Egan, D; Wilkinson, C P; Scott, C; Smith, R

    1991-04-15

    We analyzed clinical data on 22,739 contact lens wearers who were studied and whose lenses were approved under 48 manufacturer-sponsored studies for the Food and Drug Administration between 1980 and 1988. The incidence of corneal ulcers was low in the cosmetic (nontherapeutic) daily-wear soft and rigid gas-permeable lens wearers (1/1,923 and 1/1,471 patient-years, respectively). Corneal ulcers and severe adverse reactions occurred two to four times more frequently in extended-wear cosmetic soft and rigid gas-permeable lens wearers than in cosmetic daily-wear lens wearers. Aphakic extended-wear soft lens users were nine times more likely to develop a corneal ulcer when compared to the soft daily-wear cosmetic group. Corneal abrasions and keratitis accounted for 81 of 159 severe adverse reactions, whereas corneal ulcers accounted for 28 of 159 adverse reactions. The data indicate that overnight extended wear of contact lenses is associated with a greater risk of serious, sight-threatening complications than daily wear. PMID:2012148

  17. 75 FR 24708 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the... since enactment of FDAMA and has allowed 510(k) submitters to certify conformance to recognized... declarations of conformance to a recognized standard FDA believes that use of this form will simplify the...

  18. 21 CFR 880.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Provisions § 880.3... (PMA) for the device or declaring completed a product development protocol (PDP) for the device....

  19. Commercial applications

    NASA Technical Reports Server (NTRS)

    Togai, Masaki

    1990-01-01

    Viewgraphs on commercial applications of fuzzy logic in Japan are presented. Topics covered include: suitable application area of fuzzy theory; characteristics of fuzzy control; fuzzy closed-loop controller; Mitsubishi heavy air conditioner; predictive fuzzy control; the Sendai subway system; automatic transmission; fuzzy logic-based command system for antilock braking system; fuzzy feed-forward controller; and fuzzy auto-tuning system.

  20. PMGA and its application in area and power optimization for ternary FPRM circuit

    NASA Astrophysics Data System (ADS)

    Pengjun, Wang; Kangping, Li; Huihong, Zhang

    2016-01-01

    Based on the research of population migration algorithms (PMAs), a population migration genetic algorithm (PMGA) is proposed, combining a PMA with a genetic algorithm. A scheme of area and power optimization for a ternary FPRM circuit is proposed by using the PMGA. Firstly, according to the ternary FPRM logic function expression, area and power estimation models are established. Secondly, the PMGA is used to search for the best area and power polarity. Finally, 10 MCNC Benchmark circuits are used to verify the effectiveness of the proposed method. The results show that the ternary FPRM circuits optimized by the PMGA saved 13.33% area and 20.00% power on average than the corresponding FPRM circuits optimized by a whole annealing genetic algorithm. Project supported by the Natural Science Foundation of Zhejiang Province (No. LY13F040003), the National Natural Science Foundation of China (Nos. 61234002, 61306041), and the K. C. Wong Magna Fund in Ningbo University.

  1. 21 CFR 814.3 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... manufacture, processing, or packaging of a medical device. (e) PMA means any premarket approval application... therein. “PMA” includes a new drug application for a device under section 520(1) of the act. (f) PMA amendment means information an applicant submits to FDA to modify a pending PMA or a pending PMA...

  2. 21 CFR 814.3 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... manufacture, processing, or packaging of a medical device. (e) PMA means any premarket approval application... therein. “PMA” includes a new drug application for a device under section 520(1) of the act. (f) PMA amendment means information an applicant submits to FDA to modify a pending PMA or a pending PMA...

  3. ASCI applications

    SciTech Connect

    Nowak, D.A.; Christensen, R.C.

    1997-11-11

    ASCI applications codes are key elements of the Department of Energy`s Stockpile Stewardship and Management Program (SSMP). They will provide the simulation capabilities needed to predict the performance, safety, reliability, and manufacturability of the U.S. nuclear deterrent.

  4. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... Under a BLA, NDA, or PMA.'' This draft guidance intends to provide the underlying principles to... new drug application (NDA), or a device premarket approval application (PMA). DATES: Although you can..., or PMA.'' This document provides guidance to industry and FDA staff on the underlying principles...

  5. 75 FR 16365 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... significant adverse comment. In the Federal Register of November 21, 1997 (62 FR 62466), you can find... section 520(m) of the act; Any premarket approval application (PMA) or supplement to a PMA submitted under.... If the applicant of a supplement to a PMA has previously submitted information satisfying...

  6. 21 CFR 812.38 - Confidentiality of data and information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Confidentiality of data and information. (a) Existence of IDE. FDA will not disclose the existence of an IDE... application for premarket approval of the device subject to the IDE; or a notice of completion of a product... an application for an IDE for a banned device. The summary shall include information on any...

  7. 21 CFR 812.38 - Confidentiality of data and information.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Confidentiality of data and information. (a) Existence of IDE. FDA will not disclose the existence of an IDE... application for premarket approval of the device subject to the IDE; or a notice of completion of a product... an application for an IDE for a banned device. The summary shall include information on any...

  8. Food and Drug Administration Regulation of in Vitro Diagnostic Devices

    PubMed Central

    Mansfield, Elizabeth; O’Leary, Timothy J.; Gutman, Steven I.

    2005-01-01

    The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic devices. We discuss the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a premarket application or premarket notification [510(k)] pathway. We then discuss the methods that the Food and Drug Administration uses to assess the performance of in vitro diagnostic devices in the marketplace as a component of the total life cycle approach to medical device regulation. PMID:15681468

  9. Photography applications

    USGS Publications Warehouse

    Cochran, Susan A.

    2013-01-01

    Photographic imaging is the oldest form of remote sensing used in coral reef studies. This chapter briefly explores the history of photography from the 1850s to the present, and delves into its application for coral reef research. The investigation focuses on both photographs collected from low-altitude fixed-wing and rotary aircraft, and those collected from space by astronauts. Different types of classification and analysis techniques are discussed, and several case studies are presented as examples of the broad use of photographs as a tool in coral reef research.

  10. Medical Applications

    NASA Astrophysics Data System (ADS)

    Boccara, A. Claude; Mordon, Serge

    2015-10-01

    In re-listening to the lectures of Charles Townes shortly after the invention of the laser (e.g., in the Boston Science Museum), one can already have a realistic vision of the potentialities of this new tool in the field of medical therapy, as evidenced by the use of the laser in ophthalmology to cure retinal detachment in the 1960's. Since then, applications have flourished in the domain of therapy. We will thus illustrate here only some of the main fields of application of medical lasers. On the opposite, the use of lasers in medical imaging is, with one exception in ophthalmology, still at the development level. It is becoming a diagnostic tool in addition to high performance imaging facilities that are often very expensive (such as CT scan, Magnetic Resonance Imaging (MRI) and nuclear imaging). Even if progress is sometimes slow, one can now image with light inside the human body, in spite of the strong scattering of light by tissues, in the same way as a pathologist sees surgical specimens.

  11. Haptic control of a pneumatic muscle actuator to provide resistance for simulated isokinetic exercise; part II: control development and testing.

    PubMed

    Hall, Kara L; Phillips, Chandler A; Reynolds, David B; Mohler, Stanley R; Rogers, Dana B; Neidhard-Doll, Amy T

    2015-01-01

    Pneumatic muscle actuators (PMAs) have a high power to weight ratio and possess unique characteristics which make them ideal actuators for applications involving human interaction. PMAs are difficult to control due to nonlinear dynamics, presenting challenges in system implementation. Despite these challenges, PMAs have great potential as a source of resistance for strength training and rehabilitation. The objective of this work was to control a PMA for use in isokinetic exercise, potentially benefiting anyone in need of optimal strength training through a joint's range of motion. The controller, based on an inverse three-element phenomenological model and adaptive nonlinear control, allows the system to operate as a type of haptic device. A human quadriceps dynamic simulator was developed (as described in Part I of this work) so that control effectiveness and accommodation could be tested prior to human implementation. Tracking error results indicate that the control system is effective at producing PMA displacement and resistance necessary for a scaled, simulated neuromuscular actuator to maintain low-velocity isokinetic movement during simulated concentric and eccentric knee extension. PMID:23495753

  12. 75 FR 36660 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... will discuss, make recommendations and vote on a premarket approval application for the AMPLIFY rhBMP-2 Matrix, sponsored by Medtronic, Inc. The AMPLIFY rhBMP- 2 Matrix is used for posterolateral fusion... the committee. Written submissions may be made to the contact person on or before July 21, 2010....

  13. 21 CFR 3.4 - Designated agency component.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Designated agency component. 3.4 Section 3.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.4 Designated...

  14. 78 FR 50064 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-16

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Submission for... other for-profit organizations. In the Federal Register of May 2, 2013 (78 FR 25746), FDA published a 60... Component for Review of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION:...

  15. 21 CFR 870.3535 - Intra-aortic balloon and control system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... flow generation. (c) Date premarket approval application (PMA) or notice of completion of product... system indicated for septic shock or pulsatile flow generation that was in commercial distribution before... any intra-aortic balloon and control system indicated for septic shock or pulsatile flow...

  16. 21 CFR 3.7 - Request for designation.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Request for designation. 3.7 Section 3.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.7 Request for designation. (a) Who should file: the sponsor of: (1)...

  17. 21 CFR 3.5 - Procedures for identifying the designated agency component.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Procedures for identifying the designated agency component. 3.5 Section 3.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.5 Procedures for identifying...

  18. 21 CFR 3.3 - Scope.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Scope. 3.3 Section 3.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.3 Scope. This section applies to: (a)...

  19. 21 CFR 814.40 - Time frames for reviewing a PMA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Time frames for reviewing a PMA. 814.40 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.40 Time frames for reviewing a PMA. Within 180 days after receipt of an application that is accepted for filing and to...

  20. 21 CFR 814.40 - Time frames for reviewing a PMA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Time frames for reviewing a PMA. 814.40 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.40 Time frames for reviewing a PMA. Within 180 days after receipt of an application that is accepted for filing and to...

  1. 21 CFR 884.5320 - Glans sheath.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug... shall have an approved PMA or declared completed PDP in effect before being placed in...

  2. 76 FR 15321 - SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s, Petition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-21

    ... (CDRH) issued a not approvable letter in response to the premarket approval application (PMA) (PMA... healthy patients undergoing a colonoscopy or esophagogastroduodenoscopy. CDRH determined the PMA for the... data and information offered in support of the PMA did not provide a reasonable assurance that...

  3. 78 FR 12330 - Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN TRANSCATHETER...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ..., 2010, as the date the premarket approval application (PMA) for SAPIEN Transcatheter Heart Valve (PMA P100041) was initially submitted. However, FDA records indicate that PMA P100041 was submitted on November...'s claim that PMA P100041 was approved on November 2, 2011. This determination of the...

  4. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug..., 1976 shall have an approved PMA or declared completed PDP in effect before beginning...

  5. 21 CFR 814.1 - Scope.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... II; or (2) Is required to have an approved premarket approval application (PMA) or a declared... 520(1) of the act. (d) This part amends the conditions to approval for any PMA approved before the effective date of this part. Any condition to approval for an approved PMA that is inconsistent with...

  6. 78 FR 30312 - Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... notification (510(k)) or premarket approval application (PMA). In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or PMA. One example is... 510(k) or PMA) 15 times per year. The cost, not including personnel, is estimated at $52 per hour...

  7. 77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    .... On June 22, 2011 (76 FR 36542), FDA announced the availability of the draft guidance document...) Device Systems.'' On December 6, 2011 (76 FR 76166), FDA announced the availability of the draft guidance... Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for...

  8. 76 FR 75887 - SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Incorporated's...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

    ..., 2011, is cancelled. This meeting was announced in the Federal Register of November 21, 2011 (76 FR.... (See 76 FR 15321, March 21, 2011.) In the Federal Register of November 21, 2011, FDA announced that... Center for Devices and Radiological Health's (CDRH's) denial of a premarket approval application...

  9. 75 FR 54345 - Determination of Regulatory Review Period for Purposes of Patent Extension; BRYAN CERVICAL DISC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... June 28, 2006, as the date the premarket approval application (PMA) for BRYAN CERVICAL DISC SYSTEM (PMA P060023) was initially submitted. However, FDA records indicate that PMA P060023 was submitted on June 29... that PMA P060023 was approved on May 12, 2009. This determination of the regulatory review...

  10. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    .... In the Federal Register of August 15, 2011 (76 FR 50484), FDA announced the availability of the draft... assurance of safety and effectiveness of the medical device of a premarket approval application (PMA) and FDA's overall risk-benefit assessment. In some cases, a PMA may include multiple studies designed...

  11. 21 CFR 884.5320 - Glans sheath.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug... shall have an approved PMA or declared completed PDP in effect before being placed in...

  12. 21 CFR 882.5820 - Implanted cerebellar stimulator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug..., 1976 shall have an approved PMA or declared completed PDP in effect before beginning...

  13. 21 CFR 3.1 - Purpose.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Purpose. 3.1 Section 3.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.1 Purpose. This regulation relates to...

  14. 21 CFR 814.126 - Postapproval requirements and reports.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.126... of § 814.82(a)(7). In addition, medical device reports submitted to FDA in compliance with the... known or reasonably should be known to the applicant, medical device reports made under part 803 of...

  15. 75 FR 63489 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-15

    ... information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  16. 21 CFR 814.84 - Reports.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Postapproval Requirements § 814.84 Reports. (a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the...

  17. 21 CFR 814.84 - Reports.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Postapproval Requirements § 814.84 Reports. (a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the...

  18. 21 CFR 814.126 - Postapproval requirements and reports.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.126... of § 814.82(a)(7). In addition, medical device reports submitted to FDA in compliance with the... known or reasonably should be known to the applicant, medical device reports made under part 803 of...

  19. 21 CFR 814.126 - Postapproval requirements and reports.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.126... of § 814.82(a)(7). In addition, medical device reports submitted to FDA in compliance with the... known or reasonably should be known to the applicant, medical device reports made under part 803 of...

  20. 21 CFR 814.84 - Reports.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Postapproval Requirements § 814.84 Reports. (a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the...

  1. 21 CFR 3.3 - Scope.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Scope. 3.3 Section 3.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.3 Scope. This section applies to: (a)...

  2. 77 FR 39953 - Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... for large firms and $59,075 for small firms (75 FR 45641, August 3, 2010). The total cost per PMA is... response to the 515(i) Order (74 FR 16214, April 9, 2009), and any additional information that FDA has... Register: 44 FR 50512 (August 28, 1979), 48 FR 53032 (November 23, 1983), and 52 FR 17732 (May 11,...

  3. Premarket Evaluations of the IMDx C. difficile for Abbott m2000 Assay and the BD Max Cdiff Assay

    PubMed Central

    Espino, A. A.; Maceira, V. P.; Nattanmai, S. M.; Butt, S. A.; Wroblewski, D.; Hannett, G. E.; Musser, K. A.

    2014-01-01

    Clostridium difficile-associated diarrhea is a well-recognized complication of antibiotic use. Historically, diagnosing C. difficile has been difficult, as antigen assays are insensitive and culture-based methods require several days to yield results. Nucleic acid amplification tests (NAATs) are quickly becoming the standard of care. We compared the performance of two automated investigational/research use only (IUO/RUO) NAATs for the detection of C. difficile toxin genes, the IMDx C. difficile for Abbott m2000 Assay (IMDx) and the BD Max Cdiff Assay (Max). A prospective analysis of 111 stool specimens received in the laboratory for C. difficile testing by the laboratory's test of record (TOR), the BD GeneOhm Cdiff Assay, and a retrospective analysis of 88 specimens previously determined to be positive for C. difficile were included in the study. One prospective specimen was excluded due to loss to follow-up discrepancy analysis. Of the remaining 198 specimens, 90 were positive by all three methods, 9 were positive by TOR and Max, and 3 were positive by TOR only. One negative specimen was initially inhibitory by Max. The remaining 95 specimens were negative by all methods. Toxigenic C. difficile culture was performed on the 12 discrepant samples. True C. difficile-positive status was defined as either positive by all three amplification assays or positive by toxigenic culture. Based on this definition, the sensitivity and specificity were 96.9% and 95% for Max and 92.8% and 100% for IMDx. In summary, both highly automated systems demonstrated excellent performance, and each has individual benefits, which will ensure that they will both have a niche in clinical laboratories. PMID:24554744

  4. 78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ... Federal Register of July 19, 2007 (72 FR 39631), FDA announced the availability of the draft guidance... oxygen saturation (SpO 2 ) and pulse rate. This document supersedes the General Guidance Document... received with recommendations related to organization, terminology, references to standards, labeling,...

  5. Aerospace Applications of Microprocessors

    NASA Technical Reports Server (NTRS)

    1980-01-01

    An assessment of the state of microprocessor applications is presented. Current and future requirements and associated technological advances which allow effective exploitation in aerospace applications are discussed.

  6. Stirling engine application study

    SciTech Connect

    Teagan, W.P.; Cunningham, D.R.

    1983-03-01

    The potential for Stirling engine applications in the 0.5 to 5000 hp output range is assessed. The following are included: a market survey of potential engine applications, classification of applications, conventional engine markets and performance characteristics, status of Sterling engine systems, selection of application classes for Stirling engines, and the possible effects of technology, economic conditions, and regulatory changes. (MHR)

  7. Ruby on Rails Applications

    NASA Technical Reports Server (NTRS)

    Hochstadt, Jake

    2011-01-01

    Ruby on Rails is an open source web application framework for the Ruby programming language. The first application I built was a web application to manage and authenticate other applications. One of the main requirements for this application was a single sign-on service. This allowed authentication to be built in one location and be implemented in many different applications. For example, users would be able to login using their existing credentials, and be able to access other NASA applications without authenticating again. The second application I worked on was an internal qualification plan app. Previously, the viewing of employee qualifications was managed through Excel spread sheets. I built a database driven application to streamline the process of managing qualifications. Employees would be able to login securely to view, edit and update their personal qualifications.

  8. Entomopathogenic nematode application technology

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Biocontrol success when using entomopathogenic nematodes (EPNs) in the genera Heterorhabditis and Steinernema relies on a variety of factors including components of the application event itself. Successful application encompasses both abiotic and biotic influences. For example, adverse array of equi...

  9. CYBER 200 Applications Seminar

    NASA Technical Reports Server (NTRS)

    Gary, J. P. (Compiler)

    1984-01-01

    Applications suited for the CYBER 200 digital computer are discussed. Various areas of application including meteorology, algorithms, fluid dynamics, monte carlo methods, petroleum, electronic circuit simulation, biochemistry, lattice gauge theory, economics and ray tracing are discussed.

  10. Industrial storage applications overview

    NASA Technical Reports Server (NTRS)

    Duscha, R. A.

    1980-01-01

    The implementation of a technology demonstration for the food processing industry, development and technology demonstrations for selected near-term, in-plant applications and advanced industrial applications of thermal energy storage are overviewed.

  11. Biomedical Applications of Graphene

    PubMed Central

    Shen, He; Zhang, Liming; Liu, Min; Zhang, Zhijun

    2012-01-01

    Graphene exhibits unique 2-D structure and exceptional phyiscal and chemical properties that lead to many potential applications. Among various applications, biomedical applications of graphene have attracted ever-increasing interests over the last three years. In this review, we present an overview of current advances in applications of graphene in biomedicine with focus on drug delivery, cancer therapy and biological imaging, together with a brief discussion on the challenges and perspectives for future research in this field. PMID:22448195

  12. Teaching Computer Applications.

    ERIC Educational Resources Information Center

    Lundgren, Carol A.; And Others

    This document, which is designed to provide classroom teachers at all levels with practical ideas for a computer applications course, examines curricular considerations, teaching strategies, delivery techniques, and assessment methods applicable to a course focusing on applications of computers in business. The guide is divided into three…

  13. Parts application handbook study

    NASA Technical Reports Server (NTRS)

    1978-01-01

    The requirements for a NASA application handbook for standard electronic parts are determined and defined. This study concentrated on identifying in detail the type of information that designers and parts engineers need and expect in a parts application handbook for the effective application of standard parts on NASA projects.

  14. Your College Application.

    ERIC Educational Resources Information Center

    Gelband, Scott; And Others

    A guide to what college-bound students need to know to prepare the most effective college application is presented by three former college admissions officers. Step-by-step strategies are offered to help students take control of the application process and use it to their best advantage. Three basic areas of a college application are examined:…

  15. SNS application programming plan.

    SciTech Connect

    Chu, C. M.; Galambos, J. D.; Wei, J.; Allen, C.; McGehee, P. M.; Malitsky, N.

    2001-01-01

    The plan for Spallation Neutron Source accelerator physics application programs is presented. These high level applications involve processing and managing information from the diagnostic instruments, the machine control system, models and static databases and will be used to investigate and control beam behavior. Primary components include an SNS global database and Java-based XAL Application Toolkit. A key element in the SNS application programs is time synchronization of data used in these applications, due to the short pulse (1 ms), pulsed (60 Hz) nature of the device. The data synchronization progress is also presented.

  16. Engineering electrochemical capacitor applications

    NASA Astrophysics Data System (ADS)

    Miller, John R.

    2016-09-01

    Electrochemical capacitor (EC) applications have broadened tremendously since EC energy storage devices were introduced in 1978. Then typical applications operated below 10 V at power levels below 1 W. Today many EC applications operate at voltages approaching 1000 V at power levels above 100 kW. This paper briefly reviews EC energy storage technology, shows representative applications using EC storage, and describes engineering approaches to design EC storage systems. Comparisons are made among storage systems designed to meet the same application power requirement but using different commercial electrochemical capacitor products.

  17. ERIP application instructions

    SciTech Connect

    Watt, D.M.

    1992-01-02

    This report provides background information and instructions to assist applicants in writing Energy-Related Inventions Program (ERIP) applications. Initial feedback fro usage for the new instructions shows that the best instructions would not be read and followed by all applicants. Applications from more than thirty applicants who have received the new instructions indicated that few had read the instructions. Based on this feedback, the instructions have been further revised to include a title page and table of contents. A warning was also added to advise applicants of the potential penalty of delayed review if these instructions are not followed. This revision was intended to address the possibility that some applicants did not see or bother to follow the instructions which followed the background information about ERIP. Included are two examples of ERIP applications which have been prepared for handout at workshops or mailing to applicants. Writing of example applications was time consuming and more difficult than expected for several reasons: (1) Full disclosures can be lengthy, very detailed, and technical. This contrasts with the desire to prepare examples which are comparatively short and easy for the non-technical person to read. (2) Disclosures contain confidential information which should not be published. (3) It is difficult to imagine that applicants will study examples when they do not bother to read the basic instructions.

  18. Technical applications of aerogels

    SciTech Connect

    Hrubesh, L.W.

    1997-08-18

    Aerogel materials posses such a wide variety of exceptional properties that a striking number of applications have developed for them. Many of the commercial applications of aerogels such as catalysts, thermal insulation, windows, and particle detectors are still under development and new application as have been publicized since the ISA4 Conference in 1994: e.g.; supercapacitors, insulation for heat storage in automobiles, electrodes for capacitive deionization, etc. More applications are evolving as the scientific and engineering community becomes familiar with the unusual and exceptional physical properties of aerogels, there are also scientific and technical application, as well. This paper discusses a variety of applications under development at Lawrence Livermore National Laboratory for which several types of aerogels are formed in custom sizes and shapes. Particular discussions will focus on the uses of aerogels for physics experiments which rely on the exceptional, sometimes unique, properties of aerogels.

  19. Applications of MST radars: Meteorological applications

    NASA Technical Reports Server (NTRS)

    Larsen, M. F.

    1989-01-01

    Applications of mesosphere stratosphere troposphere radar to mesoscale meteorology are discussed. The applications include using the radar either as a research tool to improve our understanding of certain dynamical systems or as part of a network used to provide input data for weather forecasting. The workhorse of the operational observing network is the radiosonde balloon which provides measurements of pressure, temperature, humidity, and winds up to heights of 16 to 20 km. Horizontal and vertical measurement capabilities, reflectivity data, derivable quantities and parameters, and special operational requirements are surveyed.

  20. LANL application communication patterns

    SciTech Connect

    Pakiin, Scott

    2011-01-10

    This brief presentation describes the communication patterns used by a set of unclassified applications developed at Los Alamos National Laboratory: XNobel/XRAGE/RAGE/SAGE, Krak, Sweep3D, and Partisn. It mentions which processes communicate with which other processes, whether the application is typically run in a strong-scaling mode or a weak-scaling mode, what message sizes are commonly used, and how the application's performance changes at scale.

  1. REST based mobile applications

    NASA Astrophysics Data System (ADS)

    Rambow, Mark; Preuss, Thomas; Berdux, Jörg; Conrad, Marc

    2008-02-01

    Simplicity is the major advantage of REST based webservices. Whereas SOAP is widespread in complex, security sensitive business-to-business aplications, REST is widely used for mashups and end-user centric applicatons. In that context we give an overview of REST and compare it to SOAP. Furthermore we apply the GeoDrawing application as an example for REST based mobile applications and emphasize on pros and cons for the use of REST in mobile application scenarios.

  2. Exploiting chaos for applications

    SciTech Connect

    Ditto, William L.; Sinha, Sudeshna

    2015-09-15

    We discuss how understanding the nature of chaotic dynamics allows us to control these systems. A controlled chaotic system can then serve as a versatile pattern generator that can be used for a range of application. Specifically, we will discuss the application of controlled chaos to the design of novel computational paradigms. Thus, we present an illustrative research arc, starting with ideas of control, based on the general understanding of chaos, moving over to applications that influence the course of building better devices.

  3. Applications and Experiences

    NASA Astrophysics Data System (ADS)

    Sacco, Giovanni Maria; Ferré, Sébastien

    This chapter discusses a number of real-world applications of dynamic taxonomies. Most current applications are object-seeking or knowledge-seeking exploratory tasks, and address important areas such as e-commerce, multimedia infobases, diagnostic systems, digital libraries and news systems, e-government, file systems, and geographical information systems. Applications in these areas are discussed in detail in the following, and applications in cultural heritage, art and architecture, e-recruitment, e-hrm, e-matchmaking, e-health, and e-learning are briefly reviewed.

  4. Application Power Signature Analysis

    SciTech Connect

    Hsu, Chung-Hsing; Combs, Jacob; Nazor, Jolie; Santiago, Fabian; Thysell, Rachelle; Rivoire, Suzanne; Poole, Stephen W

    2014-01-01

    The high-performance computing (HPC) community has been greatly concerned about energy efficiency. To address this concern, it is essential to understand and characterize the electrical loads of HPC applications. In this work, we study whether HPC applications can be distinguished by their power-consumption patterns using quantitative measures in an automatic manner. Using a collection of 88 power traces from 4 different systems, we find that basic statistical measures do a surprisingly good job of summarizing applications' distinctive power behavior. Moreover, this study opens up a new area of research in power-aware HPC that has a multitude of potential applications.

  5. Nanomaterials for Defense Applications

    NASA Astrophysics Data System (ADS)

    Turaga, Uday; Singh, Vinitkumar; Lalagiri, Muralidhar; Kiekens, Paul; Ramkumar, Seshadri S.

    Nanotechnology has found a number of applications in electronics and healthcare. Within the textile field, applications of nanotechnology have been limited to filters, protective liners for chemical and biological clothing and nanocoatings. This chapter presents an overview of the applications of nanomaterials such as nanofibers and nanoparticles that are of use to military and industrial sectors. An effort has been made to categorize nanofibers based on the method of production. This chapter particularly focuses on a few latest developments that have taken place with regard to the application of nanomaterials such as metal oxides in the defense arena.

  6. Flat conductor cable applications

    NASA Technical Reports Server (NTRS)

    Angele, W.

    1972-01-01

    Some of the numerous applications of flat conductor cable (FCC) systems are briefly described. Both government and commercial uses were considered, with applications designated as either aerospace, military, or commercial. The number and variety of ways in which FCC is being applied and considered for future designs are illustrated.

  7. 76 FR 60836 - Applicants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ... applicants have filed with the Federal Maritime Commission an application for a license as a Non-Vessel...) pursuant to section 19 of the Shipping Act of 1984 as amended (46 U.S.C. chapter 409 and 46 CFR 515... Qualifying Individual (QI) for a license. Interested persons may contact the Office of...

  8. Imaging systems and applications.

    PubMed

    Bennett, Gisele; Catrysse, Peter B; Farrell, Joyce E; Fowler, Boyd; Mait, Joseph N

    2012-02-01

    Imaging systems are used in consumer, medical, and military applications. Designing, developing, and building imaging systems requires a multidisciplinary approach. This issue features current research in imaging systems that ranges from fundamental theories to novel applications. Although the papers collected are diverse, their unique compilation provides a systems perspective to imaging. PMID:22307134

  9. Application Security Automation

    ERIC Educational Resources Information Center

    Malaika, Majid A.

    2011-01-01

    With today's high demand for online applications and services running on the Internet, software has become a vital component in our lives. With every revolutionary technology comes challenges unique to its characteristics; for online applications, security is one huge concern and challenge. Currently, there are several schemes that address…

  10. Stockpiling Job Applicants.

    ERIC Educational Resources Information Center

    Bishop, John; Barron, John M.

    A study examined the way in which stockpiling job applications affects a firm's search for a new employee when an opening arises and the extent to which employers make use of applications they have stockpiled. Data on these questions were obtained from a survey of 2,264 employers that was sponsored by the National Institute of Education and the…

  11. Applications of Solubility Data

    ERIC Educational Resources Information Center

    Tomkins, Reginald P. T.

    2008-01-01

    This article describes several applications of the use of solubility data. It is not meant to be exhaustive but rather to show that knowledge of solubility data is required in a variety of technical applications that assist in the design of chemical processes. (Contains 3 figures and 1 table.)

  12. Application Statistics 1987.

    ERIC Educational Resources Information Center

    Council of Ontario Universities, Toronto.

    Summary statistics on application and registration patterns of applicants wishing to pursue full-time study in first-year places in Ontario universities (for the fall of 1987) are given. Data on registrations were received indirectly from the universities as part of their annual submission of USIS/UAR enrollment data to Statistics Canada and MCU.…

  13. Understanding University Undergraduate Applications.

    ERIC Educational Resources Information Center

    Molinero, Cecilio Mar

    1990-01-01

    Much marketing information can be obtained for admissions policy formation and forecasting from existing data sources, including course perceptions, the nature of the competition, and the admissions policies of the competition. The British university application system would benefit by exploiting computer applications of this concept. (MSE)

  14. Microcomputer Applications in Agriculture.

    ERIC Educational Resources Information Center

    Hilgenberg, Gene; And Others

    This curriculum guide is intended to assist persons teaching a course in microcomputer applications in agriculture. (These applications are designed to be used on Apple IIe or TRS-80 microcomputers.) Addressed in the individual units of instruction are the following topics: microcomputer operating procedures; procedures for evaluating and…

  15. Automatic multiple applicator electrophoresis

    NASA Technical Reports Server (NTRS)

    Grunbaum, B. W.

    1977-01-01

    Easy-to-use, economical device permits electrophoresis on all known supporting media. System includes automatic multiple-sample applicator, sample holder, and electrophoresis apparatus. System has potential applicability to fields of taxonomy, immunology, and genetics. Apparatus is also used for electrofocusing.

  16. Applications of Carbon Nanotubes

    NASA Astrophysics Data System (ADS)

    Ajayan, Pulickel M.; Zhou, Otto Z.

    Carbon nanotubes have attracted the fancy of many scientists worldwide. The small dimensions, strength and the remarkable physical properties of these structures make them a very unique material with a whole range of promising applications. In this review we describe some of the important materials science applications of carbon nanotubes. Specifically we discuss the electronic and electrochemical applications of nanotubes, nanotubes as mechanical reinforcements in high performance composites, nanotube-based field emitters, and their use as nanoprobes in metrology and biological and chemical investigations, and as templates for the creation of other nanostructures. Electronic properties and device applications of nanotubes are treated elsewhere in the book. The challenges that ensue in realizing some of these applications are also discussed from the point of view of manufacturing, processing, and cost considerations.

  17. Neutron Imaging and Applications

    SciTech Connect

    Anderson, Ian S; McGreevy, Robert L; Bilheux, Hassina Z

    2009-04-01

    Neutron Imaging and Applications offers an introduction to the basics of neutron beam production and instrumentation in addition to the wide scope of techniques that provide unique imaging capabilities over a broad and diverse range of applications. An instructional overview of neutron sources, optics and detectors, allows readers to delve more deeply into the discussions of radiography, tomography, phase contrast imaging and prospective applications using advanced neutron holography techniques and polarized beams. A section devoted to overviews in a growing range of applications describes imaging of fuel cells and hydrogen storage devices for a robust hydrogen economy; new directions in material science and engineering; the investigation of precious artifacts of cultural heritage importance; determination of plant physiology and growth processes; imaging of biological tissues and macromolecules, and the practical elements of neutron imaging for homeland security and contraband detection. Written by key experts in the field, researchers and engineers involved with imaging technologies will find Neutron Imaging and Applications a valuable reference.

  18. 49 CFR 1150.3 - Information about applicant(s).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 8 2011-10-01 2011-10-01 false Information about applicant(s). 1150.3 Section... RAILROAD LINES Applications Under 49 U.S.C. 10901 § 1150.3 Information about applicant(s). (a) The name... ownership or otherwise with any industry to be served by the line. If so, provide details about the...

  19. Stirling engine application study

    NASA Technical Reports Server (NTRS)

    Teagan, W. P.; Cunningham, D.

    1983-01-01

    A range of potential applications for Stirling engines in the power range from 0.5 to 5000 hp is surveyed. Over one hundred such engine applications are grouped into a small number of classes (10), with the application in each class having a high degree of commonality in technical performance and cost requirements. A review of conventional engines (usually spark ignition or Diesel) was then undertaken to determine the degree to which commercial engine practice now serves the needs of the application classes and to detemine the nature of the competition faced by a new engine system. In each application class the Stirling engine was compared to the conventional engines, assuming that objectives of ongoing Stirling engine development programs are met. This ranking process indicated that Stirling engines showed potential for use in all application classes except very light duty applications (lawn mowers, etc.). However, this potential is contingent on demonstrating much greater operating life and reliability than has been demonstrated to date by developmental Stirling engine systems. This implies that future program initiatives in developing Stirling engine systems should give more emphasis to life and reliability issues than has been the case in ongoing programs.

  20. OCT for industrial applications

    NASA Astrophysics Data System (ADS)

    Song, Guiju; Harding, Kevin

    2012-11-01

    Optical coherence tomography (OCT), as an interferometric method, has been studied as a distance ranger. As a technology capable of producing high-resolution, depth-resolved images of biological tissue, OCT had been widely used for the application of ophthalmology and has been commercialized in the market today. Enlightened by the emerging research interest in biomedical domain, the applications of OCT in industrial inspection were rejuvenated by a few groups to explore its potential for characterizing new materials, imaging or inspecting industrial parts as a service solution[3]. Benefiting from novel photonics components and devices, the industrial application of the older concepts in OCT can be re-visited with respect to the unique performance and availability. Commercial OCT developers such as Michelson Diagnostics (MDL; Orpington, U.K.) and Thorlabs (Newton, NJ) are actively exploring the application of OCT to industrial applications and they have outlined meaningful path toward the metrology application in emerging industry[3]. In this chapter, we will introduce the fundamental concepts of OCT and discuss its current and potential industrial applications.

  1. New applications for MOEMS

    NASA Astrophysics Data System (ADS)

    Mounier, Eric; de Charentenay, Yann; Eloy, Jean-Christophe

    2006-01-01

    In 2001, the sudden downturn of Telecom business changed the optical MEMS landscape. Some MEMS companies who were focusing only on telecom applications shut down (OMM as the most famous example) and many companies stopped their optical MEMS developments (Atmel, Memscap). However, some companies succeed to explore new applications outside the telecom area with their telecom technological platform. Today, there is a renewal of the MOEMS business and there are very interesting market opportunities for DMD. This article describes the new market trends for MOEMS and DMD applications. Several new applications are now appearing aside TV and projections systems that will widespread the use of DMDs. Maskless lithography, wavefront correction (adaptive optics) adaptive front light signal for cars, digital printing are applications currently in development where matrix of micro-mirrors could be used. Maskless lithography is still in a R&D status. It will be a low volume market but high R&D investment application that could benefit to other applications. Market acceptance may be an issue: the two main players ASML and Canon have internal projects under evaluation but it still have to prove that it is an attractive technology. Moreover, other MOEMS markets such are barcode readers, spectrometers, micro bolometers are analyzed and quantified.

  2. Wind energy applications guide

    SciTech Connect

    anon.

    2001-01-01

    The brochure is an introduction to various wind power applications for locations with underdeveloped transmission systems, from remote water pumping to village electrification. It includes an introductory section on wind energy, including wind power basics and system components and then provides examples of applications, including water pumping, stand-alone systems for home and business, systems for community centers, schools, and health clinics, and examples in the industrial area. There is also a page of contacts, plus two specific example applications for a wind-diesel system for a remote station in Antarctica and one on wind-diesel village electrification in Russia.

  3. Modeling Application Traffic

    NASA Astrophysics Data System (ADS)

    Aktas, Ismet; King, Thomas; Mengi, Cem

    Communication networks require a deep understanding of the source of generated traffic, i.e., the application. A multitude number of applications exist that generate different types of traffic, for example web, peer-to-peer, voice, and video traffic. Within the scope of performance analysis of protocols for communication networks, modeling and generating of such traffic is essential to achieve accurate and credible results. This requires that the most relevant aspects are captured by analyzing the traffic and subsequently properly represented in the application model.

  4. Biomaterials and therapeutic applications

    NASA Astrophysics Data System (ADS)

    Ferraro, Angelo

    2016-03-01

    A number of organic and inorganic, synthetic or natural derived materials have been classified as not harmful for the human body and are appropriate for medical applications. These materials are usually named biomaterials since they are suitable for introduction into living human tissues of prosthesis, as well as for drug delivery, diagnosis, therapies, tissue regeneration and many other clinical applications. Recently, nanomaterials and bioabsorbable polymers have greatly enlarged the fields of application of biomaterials attracting much more the attention of the biomedical community. In this review paper I am going to discuss the most recent advances in the use of magnetic nanoparticles and biodegradable materials as new biomedical tools.

  5. BIOSENSORS FOR ENVIRONMENTAL APPLICATIONS

    EPA Science Inventory

    A review, with 19 references, is given on challenges and possible opportunities for the development of biosensors for environmental monitoring applications. The high cost and slow turnaround times typically associated with the measurement of regulated pollutants clearly indicates...

  6. Batteries for Vehicular Applications

    NASA Astrophysics Data System (ADS)

    Srinivasan, Venkat

    2008-09-01

    This paper will describe battery technology as it relates to use in vehicular applications, including hybrid-electric vehicles (HEV), electric vehicles (EV), and plug-in-hybrid-electric vehicles (PHEV). The present status of rechargeable batteries, the requirements for each application, and the scientific stumbling blocks that stop batteries from being commercialized for these applications will be discussed. Focus will be on the class of batteries referred to as lithium batteries and the various chemistries that are the most promising for these applications. While Li-ion is expected in HEVs in the very near future, use in PHEVs are expected to be more gradual and dependent on solving the life, safety, and cost challenges. Finally, batteries for EVs remain problematic because of the range and charging-time issues.

  7. Novel Applications of Computers

    ERIC Educational Resources Information Center

    Levi, Barbara G.

    1970-01-01

    Presents some novel applications of the computer to physics research. They include (1) a computer program for calculating Compton scattering, (2) speech simulation, (3) data analysis in spectrometry, and (4) measurement of complex alpha-particle spectrum. Bibliography. (LC)

  8. Food Applications and Regulation

    NASA Astrophysics Data System (ADS)

    Gálvez, Antonio; Abriouel, Hikmate; Omar, Nabil Ben; Lucas, Rosario

    This chapter deals with food applications of bacteriocins. Regulatory issues on the different possibilities for incorporating bacteriocins as bioprotectants are discussed. Specific applications of bacteriocins or bacteriocin-producing strains are described for main food categories, including milk and dairy products, raw meats, ready-to-eat meat and poultry products, fermented meats, fish and fish products or fermented fish. The last section of the chapter deals with applications in foods and beverages derived from plant materials, such as raw vegetable foods, fruits and fruit juices, cooked food products, fermented vegetable foods and ­fermented beverages. Results obtained for application of bacteriocins in combination with other hurdles are also discussed for each specific case, with a special emphasis on novel food packaging and food-processing technologies, such as irradiation, pulsed electric field treatments or high hydrostatic pressure treatment.

  9. Applications of supercritical fluids.

    PubMed

    Brunner, Gerd

    2010-01-01

    This review discusses supercritical fluids in industrial and near-to-industry applications. Supercritical fluids are flexible tools for processing materials. Supercritical fluids have been applied to mass-transfer processes, phase-transition processes, reactive systems, materials-related processes, and nanostructured materials. Some applications are already at industrial capacity, whereas others remain under development. In addition to extraction, application areas include impregnation and cleaning, multistage countercurrent separation, particle formation, coating, and reactive systems such as hydrogenation, biomass gasification, and supercritical water oxidation. Polymers are modified with supercritical fluids, and colloids and emulsions as well as nanostructured materials exhibit interesting phenomena when in contact with supercritical fluids that can be industrially exploited. For these applications to succeed, the properties of supercritical fluids in combination with the materials processed must be clearly determined and fundamental knowledge of the complex behavior must be made readily available. PMID:22432584

  10. Neutron sources and applications

    SciTech Connect

    Price, D.L.; Rush, J.J.

    1994-01-01

    Review of Neutron Sources and Applications was held at Oak Brook, Illinois, during September 8--10, 1992. This review involved some 70 national and international experts in different areas of neutron research, sources, and applications. Separate working groups were asked to (1) review the current status of advanced research reactors and spallation sources; and (2) provide an update on scientific, technological, and medical applications, including neutron scattering research in a number of disciplines, isotope production, materials irradiation, and other important uses of neutron sources such as materials analysis and fundamental neutron physics. This report summarizes the findings and conclusions of the different working groups involved in the review, and contains some of the best current expertise on neutron sources and applications.

  11. Application Interoperability with SAMP

    NASA Astrophysics Data System (ADS)

    Fitzpatrick, M.; Laurino, O.; Paioro, L.; Taylor, M. B.

    2013-10-01

    The Simple Applications Messaging Protocol (SAMP) is a Virtual Observatory (VO) specification that enables astronomy software tools to exchange control information and data, allowing desktop applications to work as an integrated suite of tools rather than requiring complex functionality to be (redundantly) built into tools individually. In addition, SAMP allows new workflows to be created for the science user that leverages the advantages of each tool (e.g. visualization of tables or images, analysis, etc.), greatly reducing the time needed to switch between applications and tasks. We present here a short introduction to the protocol itself, a survey of some toolkits for application authors who wish to introduce SAMP functionality into their tools, and some examples of real-world usage.

  12. Space applications of superconductivity

    NASA Technical Reports Server (NTRS)

    Sullivan, D. B.; Vorreiter, J. W.

    1979-01-01

    Some potential applications of superconductivity in space are summarized, e.g., the use of high field magnets for cosmic ray analysis or energy storage and generation, space applications of digital superconducting devices, such as the Josephson switch and, in the future, a superconducting computer. Other superconducting instrumentation which could be used in space includes: low frequency superconducting sensors, microwave and infrared detectors, instruments for gravitational studies, and high-Q cavities for use as stabilizing elements in clocks and oscillators.

  13. Photovoltaic systems and applications

    SciTech Connect

    Not Available

    1982-01-01

    Abstracts are given of presentations given at a project review meeting held at Albuquerque, NM. The proceedings cover the past accomplishments and current activities of the Photovoltaic Systems Research, Balance-of-System Technology Development and System Application Experiments Projects at Sandia National Laboratories. The status of intermediate system application experiments and residential system analysis is emphasized. Some discussion of the future of the Photovoltaic Program in general, and the Sandia projects in particular is also presented.

  14. Programmable Logic Application Notes

    NASA Technical Reports Server (NTRS)

    Katz, Richard

    1998-01-01

    This column will be provided each quarter as a source for reliability, radiation results, NASA capabilities, and other information on programmable logic devices and related applications. This quarter's column will include some announcements and some recent radiation test results and evaluations of interest. Specifically, the following topics will be covered: the Military and Aerospace Applications of Programmable Devices and Technologies Conference to be held at GSFC in September, 1998, proton test results, heavy ion test results, and some total dose results.

  15. Programmable Logic Application Notes

    NASA Technical Reports Server (NTRS)

    Katz, Richard

    1998-01-01

    This column will be provided each quarter as a source for reliability, radiation results, NASA capabilities, and other information on programmable logic devices and related applications. This quarter's column will include some announcements and some recent radiation test results and evaluations of interest. Specifically, the following topics will be covered: the Military and Aerospace Applications of Programmable Devices and Technologies Conference to be held at GSFC in September, 1998, proton test results, and some total dose results.

  16. Applications of immunohistochemistry

    PubMed Central

    Duraiyan, Jeyapradha; Govindarajan, Rajeshwar; Kaliyappan, Karunakaran; Palanisamy, Murugesan

    2012-01-01

    Immunohistochemistry (IHC) is an important application of monoclonal as well as polyclonal antibodies to determine the tissue distribution of an antigen of interest in health and disease. IHC is widely used for diagnosis of cancers; specific tumor antigens are expressed de novo or up-regulated in certain cancers. This article deals with the various applications of IHC in diagnosis of diseases, with IHC playing an important role in diagnostic and research laboratories. PMID:23066277

  17. LED applications in biomedicine

    NASA Astrophysics Data System (ADS)

    Liu, Timon C.; Huang, Ping; Liu, Jiang; Yin, Jian-Ling; Fan, Guang-Han; Liu, Song-Hao

    2003-12-01

    Light-emitting diode (LED) technology has provided medicine with a new tool capable of delivering light deep into tissues of the body, at wavelengths which are biologically optimal for cancer treatment, wound healing and other clinical applications. In this paper, a simple review on the clinical use in therapeutic applications as well as in laboratory work of LEDs is given in view of low intensity laser irradiation effects in biomedicine.

  18. Applications Of Artificial Intelligence

    NASA Astrophysics Data System (ADS)

    Trivedi, Mohan M.; Gilmore, John F.

    1986-03-01

    Intelligence evolves out of matter, so said the Sankhya philosophers of ancient India. The discipline of artificial intelligence (Al), which was established some 30 years ago, has confirmed the validity of the above assertion. Recently, a number of AI applications have been successfully demonstrated, generating a great deal of excitement and interest in scientific and technical circles. In this special issue of Optical Engineering a representative set of applications that incorporate Al principles is presented.

  19. Applications of cavity optomechanics

    SciTech Connect

    Metcalfe, Michael

    2014-09-15

    “Cavity-optomechanics” aims to study the quantum properties of mechanical systems. A common strategy implemented in order to achieve this goal couples a high finesse photonic cavity to a high quality factor mechanical resonator. Then, using feedback forces such as radiation pressure, one can cool the mechanical mode of interest into the quantum ground state and create non-classical states of mechanical motion. On the path towards achieving these goals, many near-term applications of this field have emerged. After briefly introducing optomechanical systems and describing the current state-of-the-art experimental results, this article summarizes some of the more exciting practical applications such as ultra-sensitive, high bandwidth accelerometers and force sensors, low phase noise x-band integrated microwave oscillators and optical signal processing such as optical delay-lines, wavelength converters, and tunable optical filters. In this rapidly evolving field, new applications are emerging at a fast pace, but this article concentrates on the aforementioned lab-based applications as these are the most promising avenues for near-term real-world applications. New basic science applications are also becoming apparent such as the generation of squeezed light, testing gravitational theories and for providing a link between disparate quantum systems.

  20. LCS Content Document Application

    NASA Technical Reports Server (NTRS)

    Hochstadt, Jake

    2011-01-01

    My project at KSC during my spring 2011 internship was to develop a Ruby on Rails application to manage Content Documents..A Content Document is a collection of documents and information that describes what software is installed on a Launch Control System Computer. It's important for us to make sure the tools we use everyday are secure, up-to-date, and properly licensed. Previously, keeping track of the information was done by Excel and Word files between different personnel. The goal of the new application is to be able to manage and access the Content Documents through a single database backed web application. Our LCS team will benefit greatly with this app. Admin's will be able to login securely to keep track and update the software installed on each computer in a timely manner. We also included exportability such as attaching additional documents that can be downloaded from the web application. The finished application will ease the process of managing Content Documents while streamlining the procedure. Ruby on Rails is a very powerful programming language and I am grateful to have the opportunity to build this application.

  1. Technology Applications Team: Applications of aerospace technology

    NASA Technical Reports Server (NTRS)

    1993-01-01

    Highlights of the Research Triangle Institute (RTI) Applications Team activities over the past quarter are presented in Section 1.0. The Team's progress in fulfilling the requirements of the contract is summarized in Section 2.0. In addition to our market-driven approach to applications project development, RTI has placed increased effort on activities to commercialize technologies developed at NASA Centers. These Technology Commercialization efforts are summarized in Section 3.0. New problem statements prepared by the Team in the reporting period are presented in Section 4.0. The Team's transfer activities for ongoing projects with the NASA Centers are presented in Section 5.0. Section 6.0 summarizes the status of four add-on tasks. Travel for the reporting period is described in Section 7.0. The RTI Team staff and consultants and their project responsibilities are listed in Appendix A. The authors gratefully acknowledge the contributions of many individuals to the RTI Technology Applications Team program. The time and effort contributed by managers, engineers, and scientists throughout NASA were essential to program success. Most important to the program has been a productive working relationship with the NASA Field Center Technology Utilization (TU) Offices. The RTI Team continues to strive for improved effectiveness as a resource to these offices. Industry managers, technical staff, medical researchers, and clinicians have been cooperative and open in their participation. The RTI Team looks forward to continuing expansion of its interaction with U.S. industry to facilitate the transfer of aerospace technology to the private sector.

  2. Application technology for entomopathogenic nematodes

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Diverse technology is available for the application of entomopathogenic nematodes. Application usually consists of nematode distribution via aqueous suspension in various irrigation systems and spray equipment. The choice of application equipment, and method in which the nematodes are applied, can...

  3. Computer Applications in Educational Audiology.

    ERIC Educational Resources Information Center

    Mendel, Lisa Lucks; And Others

    1995-01-01

    This article provides an overview of how computer technologies can be used by educational audiologists. Computer technologies are classified into three categories: (1) information systems applications; (2) screening and diagnostic applications; and (3) intervention applications. (Author/DB)

  4. Tissue Engineered Constructs: Perspectives on Clinical Translation

    PubMed Central

    Lu, Lichun; Arbit, Harvey M.; Herrick, James L.; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J.

    2015-01-01

    In this article, a “bedside to bench and back” approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the US Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or New Drug Application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented. PMID:25711151

  5. Tissue engineered constructs: perspectives on clinical translation.

    PubMed

    Lu, Lichun; Arbit, Harvey M; Herrick, James L; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J

    2015-03-01

    In this article, a "bedside to bench and back" approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the U.S. Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or new drug application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented. PMID:25711151

  6. Batteries for terrestrial applications

    SciTech Connect

    Kulin, T.M.

    1998-07-01

    Extensive research has been conducted in the design and manufacture of very long life vented and sealed maintenance free nickel-cadmium aircraft batteries. These batteries have also been used in a number of terrestrial applications with good success. This study presents an overview of the Ni-Cd chemistry and technology as well as detailed analysis of the advantages and disadvantages of the Ni-Cd couple for terrestrial applications. The performance characteristics of both sealed and vented Ni-Cd's are presented. Various charge algorithms are examined and evaluated for effectiveness and ease of implementation. Hardware requirements for charging are also presented and evaluated. The discharge characteristics of vented and sealed Ni-Cd's are presented and compared to other battery chemistries. The performance of Ni-Cd's under extreme environmental conditions is also compared to other battery chemistries. The history of various terrestrial applications is reviewed and some of the lessons learned are presented. Applications discussed include the NASA Middeck Payload Battery, Raytheon Aegis Missile System Battery, THAAD Launcher battery, and the Titan IV battery. The suitability of the Ni-Cd chemistry for other terrestrial applications such as electric vehicles and Uninterruptible Power Supply is discussed.

  7. Plastics in medical applications.

    PubMed

    Lantos, P R

    1988-01-01

    Plastics are fulfilling a number of critical roles in a variety of medical applications. While some of these are low-technology, throw-away products, many of the applications impose critical requirements as to mechanical performance, chemical resistance, biocompatibility, ability to be sterilized and to remain sterile. By performing capably and reliably in these applications, plastics have found a major outlet, one that offers good opportunities for the present materials as well as for future developments. Numerous challenges remain. The present materials perform, though barely adequately, and superior performance over longer periods of time is an important goal. While off-the-shelf plastics have been used in most medical applications, it is likely that development work will focus on the needs of specific important medical applications. In addition to the usual need for ever decreasing costs and prices, there is the opportunity for materials that possess improved blood compatibility, radiation resistance, and/or in vivo compatibility for improved degradable sutures, coatings for pacemakers, phthalate-free plastics, bags with improved gas impermeability and disposables with controlled degradability. PMID:3230510

  8. Multiphysics Application Coupling Toolkit

    SciTech Connect

    Campbell, Michael T.

    2013-12-02

    This particular consortium implementation of the software integration infrastructure will, in large part, refactor portions of the Rocstar multiphysics infrastructure. Development of this infrastructure originated at the University of Illinois DOE ASCI Center for Simulation of Advanced Rockets (CSAR) to support the center's massively parallel multiphysics simulation application, Rocstar, and has continued at IllinoisRocstar, a small company formed near the end of the University-based program. IllinoisRocstar is now licensing these new developments as free, open source, in hopes to help improve their own and others' access to infrastructure which can be readily utilized in developing coupled or composite software systems; with particular attention to more rapid production and utilization of multiphysics applications in the HPC environment. There are two major pieces to the consortium implementation, the Application Component Toolkit (ACT), and the Multiphysics Application Coupling Toolkit (MPACT). The current development focus is the ACT, which is (will be) the substrate for MPACT. The ACT itself is built up from the components described in the technical approach. In particular, the ACT has the following major components: 1.The Component Object Manager (COM): The COM package provides encapsulation of user applications, and their data. COM also provides the inter-component function call mechanism. 2.The System Integration Manager (SIM): The SIM package provides constructs and mechanisms for orchestrating composite systems of multiply integrated pieces.

  9. Nonlinear Optics and Applications

    NASA Technical Reports Server (NTRS)

    Abdeldayem, Hossin A. (Editor); Frazier, Donald O. (Editor)

    2007-01-01

    Nonlinear optics is the result of laser beam interaction with materials and started with the advent of lasers in the early 1960s. The field is growing daily and plays a major role in emerging photonic technology. Nonlinear optics play a major role in many of the optical applications such as optical signal processing, optical computers, ultrafast switches, ultra-short pulsed lasers, sensors, laser amplifiers, and many others. This special review volume on Nonlinear Optics and Applications is intended for those who want to be aware of the most recent technology. This book presents a survey of the recent advances of nonlinear optical applications. Emphasis will be on novel devices and materials, switching technology, optical computing, and important experimental results. Recent developments in topics which are of historical interest to researchers, and in the same time of potential use in the fields of all-optical communication and computing technologies, are also included. Additionally, a few new related topics which might provoke discussion are presented. The book includes chapters on nonlinear optics and applications; the nonlinear Schrodinger and associated equations that model spatio-temporal propagation; the supercontinuum light source; wideband ultrashort pulse fiber laser sources; lattice fabrication as well as their linear and nonlinear light guiding properties; the second-order EO effect (Pockels), the third-order (Kerr) and thermo-optical effects in optical waveguides and their applications in optical communication; and, the effect of magnetic field and its role in nonlinear optics, among other chapters.

  10. Multiphysics Application Coupling Toolkit

    Energy Science and Technology Software Center (ESTSC)

    2013-12-02

    This particular consortium implementation of the software integration infrastructure will, in large part, refactor portions of the Rocstar multiphysics infrastructure. Development of this infrastructure originated at the University of Illinois DOE ASCI Center for Simulation of Advanced Rockets (CSAR) to support the center's massively parallel multiphysics simulation application, Rocstar, and has continued at IllinoisRocstar, a small company formed near the end of the University-based program. IllinoisRocstar is now licensing these new developments as free, openmore » source, in hopes to help improve their own and others' access to infrastructure which can be readily utilized in developing coupled or composite software systems; with particular attention to more rapid production and utilization of multiphysics applications in the HPC environment. There are two major pieces to the consortium implementation, the Application Component Toolkit (ACT), and the Multiphysics Application Coupling Toolkit (MPACT). The current development focus is the ACT, which is (will be) the substrate for MPACT. The ACT itself is built up from the components described in the technical approach. In particular, the ACT has the following major components: 1.The Component Object Manager (COM): The COM package provides encapsulation of user applications, and their data. COM also provides the inter-component function call mechanism. 2.The System Integration Manager (SIM): The SIM package provides constructs and mechanisms for orchestrating composite systems of multiply integrated pieces.« less

  11. 37 CFR 1.421 - Applicant for international application.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Applicant for international..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES International Processing Provisions Who May File An International Application § 1.421 Applicant for international application. (a) Only...

  12. 37 CFR 1.421 - Applicant for international application.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Applicant for international..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES International Processing Provisions Who May File An International Application § 1.421 Applicant for international application. (a) Only...

  13. 37 CFR 1.421 - Applicant for international application.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Applicant for international..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES International Processing Provisions Who May File An International Application § 1.421 Applicant for international application. (a) Only...

  14. 37 CFR 1.421 - Applicant for international application.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Applicant for international..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES International Processing Provisions Who May File An International Application § 1.421 Applicant for international application. (a) Only...

  15. 37 CFR 1.421 - Applicant for international application.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Applicant for international..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES International Processing Provisions Who May File An International Application § 1.421 Applicant for international application. (a) Only...

  16. Data management applications

    NASA Technical Reports Server (NTRS)

    1983-01-01

    Kennedy Space Center's primary institutional computer is a 4 megabyte IBM 4341 with 3.175 billion characters of IBM 3350 disc storage. This system utilizes the Software AG product known as ADABAS with the on line user oriented features of NATURAL and COMPLETE as a Data Base Management System (DBMS). It is operational under the OS/VSI and is currently supporting batch/on line applications such as Personnel, Training, Physical Space Management, Procurement, Office Equipment Maintenance, and Equipment Visibility. A third and by far the largest DBMS application is known as the Shuttle Inventory Management System (SIMS) which is operational on a Honeywell 6660 (dedicated) computer system utilizing Honeywell Integrated Data Storage I (IDSI) as the DBMS. The SIMS application is designed to provide central supply system acquisition, inventory control, receipt, storage, and issue of spares, supplies, and materials.

  17. APTASENSORS FOR BIOSECURITY APPLICATIONS

    SciTech Connect

    Fischer, N; Tarasow, T; Tok, J

    2007-01-03

    Nucleic acid aptamers have found steadily increased utility and application steadily over the last decade. In particular, aptamers have been touted as a valuable complement to and in some cases replacement for antibodies due to their structural and functional robustness as well as their ease in generation and synthesis. They are thus attractive for biosecurity applications, e.g. pathogen detection, and are especially well suited since their in vitro generation process does not require infection of any host systems. Herein we provide a brief overview of the aptamers generated against biopathogens over the last few years. In addition, a few recently described detection platforms using aptamers (aptasensors) and potentially suitable for biosecurity applications will be discussed.

  18. Applications of aerospace technology

    NASA Technical Reports Server (NTRS)

    Rouse, Doris J.

    1984-01-01

    The objective of the Research Triangle Institute Technology Transfer Team is to assist NASA in achieving widespread utilization of aerospace technology in terrestrial applications. Widespread utilization implies that the application of NASA technology is to benefit a significant sector of the economy and population of the Nation. This objective is best attained by stimulating the introduction of new or improved commercially available devices incorporating aerospace technology. A methodology is presented for the team's activities as an active transfer agent linking NASA Field Centers, industry associations, user groups, and the medical community. This methodology is designed to: (1) identify priority technology requirements in industry and medicine, (2) identify applicable NASA technology that represents an opportunity for a successful solution and commercial product, (3) obtain the early participation of industry in the transfer process, and (4) successfully develop a new product based on NASA technology.

  19. 21 CFR 814.45 - Denial of approval of a PMA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Denial of approval of a PMA. 814.45 Section 814.45...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.45 Denial of approval of a PMA. (a) FDA may issue an order denying approval of a PMA if the applicant fails to follow...

  20. 21 CFR 814.45 - Denial of approval of a PMA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Denial of approval of a PMA. 814.45 Section 814.45...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.45 Denial of approval of a PMA. (a) FDA may issue an order denying approval of a PMA if the applicant fails to follow...

  1. Location Based Application Availability

    NASA Astrophysics Data System (ADS)

    Naeem Akram, Raja; Markantonakis, Konstantinos; Mayes, Keith

    Smart cards are being integrated into a diverse range of industries: ranging from banking, telecom, transport, home/office access control to health and E-passport. Traditionally, cardholders are required to carry a smart card for each application. However, recent developments in the Near Field Communication (NFC) have renewed the interest in multiple applications for different services on a single device. This paper builds onto the NFC initiative and avoids the smart card ownership issues that hinder the adoption of such devices. The proposal integrates the Global Positioning System with the NFC in mobile phones to provide a ubiquitously and flexible service access model.

  2. Applications of fuzzy logic

    SciTech Connect

    Zargham, M.R.

    1995-06-01

    Recently, fuzzy logic has been applied to many areas, such as process control, image understanding, robots, expert systems, and decision support systems. This paper will explain the basic concepts of fuzzy logic and its application in different fields. The steps to design a control system will be explained in detail. Fuzzy control is the first successful industrial application of fuzzy logic. A fuzzy controller is able to control systems which previously could only be controlled by skilled operators. In recent years Japan has achieved significant progress in this area and has applied it to variety of products such as cruise control for cars, video cameras, rice cookers, washing machines, etc.

  3. National information infrastructure applications

    SciTech Connect

    Forslund, D.; George, J.; Greenfield, J.

    1996-07-01

    This is the final report of a two-year, Laboratory-Directed Research and Development (LDRD) project at the Los Alamos National Laboratory (LANL). This project sought to develop a telemedical application in which medical records are electronically searched and digital signatures of real CT scan data are indexed and used to characterize a range of diseases and are used to compare on-line medical data with archived clinical data rapidly. This system includes multimedia data management, interactive collaboration, data compression and transmission, remote data storage and retrieval, and automated data analysis integrated in a distributed application between Los Alamos and the National Jewish Hospital.

  4. Polyimide composites: Application histories

    NASA Technical Reports Server (NTRS)

    Poveromo, L. M.

    1985-01-01

    Advanced composite hardware exposed to thermal environments above 127 C (260 F) must be fabricated from materials having resin matrices whose thermal/moisture resistance is superior to that of conventional epoxy-matrix systems. A family of polyimide resins has evolved in the last 10 years that exhibits the thermal-oxidative stability required for high-temperature technology applications. The weight and structural benefits for organic-matrix composites can now be extended by designers and materials engineers to include structures exposed to 316 F (600 F). Polyimide composite materials are now commercially available that can replace metallic or epoxy composite structures in a wide range of aerospace applications.

  5. Science Application Teams

    NASA Technical Reports Server (NTRS)

    2000-01-01

    This paper discusses the science application team activities. Science Application team are: (1) Represent the diversity of NASA onboard computing of the future. (2) Drive architecture and system software requirements. (3) Demonstrate the benefit of highly capable computing onboard. (4) Study the birth of the first galaxies. (5) Study formation of stars. (6) Discusses the next generation space telescope hardware/software requirement: image processing and on-board optical calibration. Also discusses gamma ray large area space telescope; orbital thermal imaging spectrometer; solar terrestrial probe program; autonomous Mars rover;fault tolerance and errors.

  6. Future communications satellite applications

    NASA Technical Reports Server (NTRS)

    Bagwell, James W.

    1992-01-01

    The point of view of the research is made through the use of viewgraphs. It is suggested that future communications satellite applications will be made through switched point to point narrowband communications. Some characteristics of which are as follows: small/low cost terminals; single hop communications; voice compatible; full mesh networking; ISDN compatible; and possible limited use of full motion video. Some target applications are as follows: voice/data networks between plants and offices in a corporation; data base networking for commercial and science users; and cellular radio internodal voice/data networking.

  7. Elastomers for biomedical applications.

    PubMed

    Yoda, R

    1998-01-01

    Current topics in elastomers for biomedical applications are reviewed. Elastomeric biomaterials, such as silicones, thermoplastic elastomers, polyolefin and polydiene elastomers, poly(vinyl chloride), natural rubber, heparinized polymers, hydrogels, polypeptides elastomers and others are described. In addition biomedical applications, such as cardiovascular devices, prosthetic devices, general medical care products, transdermal therapeutic systems, orthodontics, and ophthalmology are reviewed as well. Elastomers will find increasing use in medical products, offering biocompatibility, durability, design flexibility, and favorable performance/cost ratios. Elastomers will play a key role in medical technology of the future. PMID:9659600

  8. Microgravity Science and Applications

    NASA Technical Reports Server (NTRS)

    1986-01-01

    The report presents fifteen papers from a workshop on microgravity science and applications held at the Jet Propulsion Laboratory in Pasadena, California, on December 3 to 4, 1984. The workshop and panel were formed by the Solid State Sciences Committee of the Board on Physics and Astronomy of the National Research Council in response to a request from the Office of Science and Technology Policy. The goal was to review the microgravity science and applications (MSA) program of NASA and to evaluate the quality of the program. The topics for the papers are metals and alloys, electronic materials, ceramics and glasses, biotechnology, combustion science, and fluid dynamics.

  9. Medical applications of microwaves

    NASA Astrophysics Data System (ADS)

    Vrba, Jan; Lapes, M.

    2004-04-01

    Medical applications of microwaves (i.e. a possibility to use microwave energy and/or microwave technique and technology for therapeutical purposes) are a quite new and a very rapidly developing field. Microwave thermotherapy is being used in medicine for the cancer treatment and treatment of some other diseases since early eighties. In this contribution we would like to offer general overview of present activities in the Czech Republic, i.e. clinical applications and results, technical aspects of thermo therapeutic equipment and last but not least, prospective diagnostics based on microwave principals ant technology and instrumentation.

  10. Applications of Superconductivity

    ERIC Educational Resources Information Center

    Goodkind, John M.

    1971-01-01

    Presents a general review of current practical applications of the properties of superconducters. The devices are classified into groups according to the property that is of primary importance. The article is inteded as a first introduction for students and professionals. (Author/DS)

  11. Optical Scanning Applications.

    ERIC Educational Resources Information Center

    Wagner, Hans

    The successful use of optical scanning at the University of the Pacific (UOP) indicates that such techniques can simplify a number of administrative data processing tasks. Optical scanning is regularly used at UOP to assist with data processing in the areas of admissions, registration and grade reporting and also has applications for other tasks…

  12. Arizona's Application Service Provider.

    ERIC Educational Resources Information Center

    Jordan, Darla

    2002-01-01

    Describes the U.S.'s first statewide K-12 application service provider (ASP). The ASP, implemented by the Arizona School Facilities Board, provides access to productivity, communications, and education software programs from any Internet-enabled device, whether in the classroom or home. (EV)

  13. Overview 1993: Computational applications

    NASA Technical Reports Server (NTRS)

    Benek, John A.

    1993-01-01

    Computational applications include projects that apply or develop computationally intensive computer programs. Such programs typically require supercomputers to obtain solutions in a timely fashion. This report describes two CSTAR projects involving Computational Fluid Dynamics (CFD) technology. The first, the Parallel Processing Initiative, is a joint development effort and the second, the Chimera Technology Development, is a transfer of government developed technology to American industry.

  14. Clinical Application of Electrocardiography.

    ERIC Educational Resources Information Center

    Brammell, H. L.; Orr, William

    The scalar electrocardiogram (ECG) is one of the most important and commonly used clinical tools in medicine. A detailed description of the recordings of cardiac electrical activity made by the ECG is presented, and the vast numbers of uses made with the data provided by this diagnostic tool are cited. Clinical applications of the ECG are listed.…

  15. Evaluating Multimedia Applications.

    ERIC Educational Resources Information Center

    Yildiz, Rauf; Atkins, Madeleine

    1993-01-01

    Reviews and analyzes criticisms of the design of media evaluation studies; suggests guidelines for future evaluation studies, including analyses of learning theories and desired learning outcomes; and describes the application of the evaluative guidelines to an interactive video in an English comprehensive school with 14-year-olds. (Contains 26…

  16. VCSEL Applications and Simulation

    NASA Technical Reports Server (NTRS)

    Cheung, Samson; Goorjian, Peter; Ning, Cun-Zheng; Li, Jian-Zhong

    2000-01-01

    This viewgraph presentation gives an overview of Vertical Cavity Surface Emitting Laser (VCSEL) simulation and its applications. Details are given on the optical interconnection in information technology of VCSEL, the formulation of the simulation, its numeric algorithm, and the computational results.

  17. Microcomputer Applications Specialist.

    ERIC Educational Resources Information Center

    Ohio State Univ., Columbus. Center on Education and Training for Employment.

    This publication contains 16 subjects appropriate for use in a competency list for the occupation of microcomputer applications specialist, 1 of 12 occupations within the business/computer technologies cluster. Each unit consists of a number of competencies; a list of competency builders is provided for each competency. Titles of the 16 units are…

  18. Core Design Applications

    Energy Science and Technology Software Center (ESTSC)

    1995-07-12

    CORD-2 is intended for core desigh applications of pressurized water reactors. The main objective was to assemble a core design system which could be used for simple calculations (such as frequently required for fuel management) as well as for accurate calculations (for example, core design after refueling).

  19. Permit application modifications

    SciTech Connect

    1995-11-01

    This document contains the Permit Application Modifications for the Y-12 Industrial Landfill V site on the Oak Ridge Reservation. These modifications include the assessment of stability of the proposed Landfill V under static and loading conditions. Analyses performed include the general slope stability, veneer stability of the bottom liner and cover system, and a liquefaction potential assessment of the foundation soils.

  20. Business Applications of WAP.

    ERIC Educational Resources Information Center

    van Steenderen, Margaret

    2002-01-01

    Explains the development of WAP (wireless application protocol), how it works, and what the major advantages and disadvantages are, especially when applied to the use of information. Topics include standardization; mobile communications; the effect of WAP on business tools, electronic commerce, and information services; consumers; corporate users;…

  1. AGU membership applications

    NASA Astrophysics Data System (ADS)

    Applications for membership have been received from the following individuals. The letter after the name denotes the proposed primary section affiliation. Donald K. Balmer (H), Mark Bushnell (O), Charles J . Garcia (SS), Enzo Mantovani (S), Vicky Pease (T), James E. Quick (V), Gerard Schuster (S), Endre Skaar, Michael Underwood (T), J o hn J . Whipple (H).

  2. Microcontroller for automation application

    NASA Technical Reports Server (NTRS)

    Cooper, H. W.

    1975-01-01

    The description of a microcontroller currently being developed for automation application was given. It is basically an 8-bit microcomputer with a 40K byte random access memory/read only memory, and can control a maximum of 12 devices through standard 15-line interface ports.

  3. Medical applications of holography

    NASA Astrophysics Data System (ADS)

    von Bally, Gert

    1991-11-01

    From the various capabilities of holography for image processing and measuring purposes, holographic interferometric techniques have found more extended application in biological and medical research. Due to their special properties the different methods of holographic interferometry are applied to characteristic fields of biomedical investigations where--similar to nondestructive testing--vibration and deformation analysis is of interest. Features of holographic interferometry, such as the possibility of noncontactive, three-dimensional investigations with a large field-of-depth, are used with advantage. The main applications can be found in basic research e.g., in audiology, dentistry, opthalmology, and experimental orthopedics. Because of the great number of investigations and the variety of medical domains in which these investigations were performed this survey is confined to some characteristic examples. As in all fields of optics and laser metrology, a review on biomedical applications of holography would be incomplete if military developments and utilization were not mentioned. As demonstrated by selected examples, the increasing interlacing of science with the military does not stop at domains that traditionally are regarded as exclusively oriented to human welfare--like biomedical research. The term ''Star Wars Medicine'', which becomes an increasingly popular expression for laser applications (including holography) in medicine, characterizes the consequences of this development.

  4. Adaptive Sampling Proxy Application

    Energy Science and Technology Software Center (ESTSC)

    2012-10-22

    ASPA is an implementation of an adaptive sampling algorithm [1-3], which is used to reduce the computational expense of computer simulations that couple disparate physical scales. The purpose of ASPA is to encapsulate the algorithms required for adaptive sampling independently from any specific application, so that alternative algorithms and programming models for exascale computers can be investigated more easily.

  5. Computer Applications for Children.

    ERIC Educational Resources Information Center

    Dulsky, Dwight; And Others

    1993-01-01

    Four articles discuss computer-assisted instruction, including (1) a middle school art and computer departments project that used LOGO to create rose window designs; (2) student journals; (3) the application of Piaget constructivism and Vygotskin social interaction to LOGO learning; and (4) computer lab writing workshops for elementary school…

  6. Mobile Agents Applications.

    ERIC Educational Resources Information Center

    Martins, Rosane Maria; Chaves, Magali Ribeiro; Pirmez, Luci; Rust da Costa Carmo, Luiz Fernando

    2001-01-01

    Discussion of the need to filter and retrieval relevant information from the Internet focuses on the use of mobile agents, specific software components which are based on distributed artificial intelligence and integrated systems. Surveys agent technology and discusses the agent building package used to develop two applications using IBM's Aglet…

  7. Geophysical applications of squids

    SciTech Connect

    Clarke, J.

    1983-05-01

    Present and potential geophysical applications of Superconducting Quantum Interference Devices (SQUIDs) include remote reference magnetotellurics, controlledsource electromagnetic sounding, airborne gradiometry, gravity gradiometers, rock magnetism, paleomagnetism, piezomagnetism, tectonomagnetism, the location of hydrofractures for hot dry rock geothermal energy and enhanced oil and gas recovery, the detection of internal ocean waves, and underwater magnetotellurics.

  8. Forensic Applications of LIBS

    NASA Astrophysics Data System (ADS)

    Hark, Richard R.; East, Lucille J.

    Forensic science is broadly defined as the application of science to matters of the law. Practitioners typically use multidisciplinary scientific techniques for the analysis of physical evidence in an attempt to establish or exclude an association between a suspect and the scene of a crime.

  9. Applications of aerospace technology

    NASA Technical Reports Server (NTRS)

    Rouse, D. J.; Brown, J. N., Jr.; Cleland, John; Lehrman, Stephen; Trachtman, Lawrence; Wallace, Robert; Winfield, Daniel; Court, Nancy; Maggin, Bernard; Barnett, Reed

    1987-01-01

    Highlights are presented for the Research Triangle Institute (RTI) Applications Team activities over the past quarter. Progress in fulfilling the requirements of the contract is summarized, along with the status of the eight add-on tasks. New problem statements are presented. Transfer activities for ongoing projects with the NASA Centers are included.

  10. Biomedical applications engineering tasks

    NASA Technical Reports Server (NTRS)

    Laenger, C. J., Sr.

    1976-01-01

    The engineering tasks performed in response to needs articulated by clinicians are described. Initial contacts were made with these clinician-technology requestors by the Southwest Research Institute NASA Biomedical Applications Team. The basic purpose of the program was to effectively transfer aerospace technology into functional hardware to solve real biomedical problems.

  11. TIGER Arc Modification Application

    SciTech Connect

    Armstrong, Hillary

    1995-03-06

    The application enables the geometric correction of TIGER arcs to a more accurate spatial data set. This is done in a structured automated environment according to Census Bureau guidelines and New Mexico state GIS standards. Arcs may be deleted, added, combined, split, and moved relative to a coverage or image displayed in the background.

  12. Programmable Logic Application Notes

    NASA Technical Reports Server (NTRS)

    Katz, Richard

    2000-01-01

    This column will be provided each quarter as a source for reliability, radiation results, NASA capabilities, and other information on programmable logic devices and related applications. This quarter will start a series of notes concentrating on analysis techniques with this issues section discussing worst-case analysis requirements.

  13. Programmable Logic Application Notes

    NASA Technical Reports Server (NTRS)

    Katz, Richard; Day, John H. (Technical Monitor)

    2001-01-01

    This report will be provided each quarter as a source for reliability, radiation results, NASA capabilities, and other information on programmable logic devices and related applications. This quarter will continue a series of notes concentrating on analysis techniques with this issue's section discussing the use of Root-Sum-Square calculations for digital delays.

  14. Transducer applications, a compilation

    NASA Technical Reports Server (NTRS)

    1972-01-01

    The characteristics and applications of transducers are discussed. Subjects presented are: (1) thermal measurements, (2) liquid level and fluid flow measurements, (3) pressure transducers, (4) stress-strain measurements, (5) acceleration and velocity measurements, (6) displacement and angular rotation, and (7) transducer test and calibration methods.

  15. Applications Using AIRS Data

    NASA Astrophysics Data System (ADS)

    Ray, S. E.; Pagano, T. S.; Fetzer, E. J.; Lambrigtsen, B.; Olsen, E. T.; Teixeira, J.; Licata, S. J.; Hall, J. R.; Thompson, C. K.

    2015-12-01

    The Atmospheric Infrared Sounder (AIRS) on NASA's Aqua spacecraft has been returning daily global observations of Earth's atmospheric constituents and properties since 2002. With a 12-year data record and daily, global observations in near real-time, AIRS data can play a role in applications that fall under many of the NASA Applied Sciences focus areas. For vector-borne disease, research is underway using AIRS near surface retrievals to assess outbreak risk, mosquito incubation periods and epidemic potential for dengue fever, malaria, and West Nile virus. For drought applications, AIRS temperature and humidity data are being used in the development of new drought indicators and improvement in the understanding of drought development. For volcanic hazards, new algorithms using AIRS data are in development to improve the reporting of sulfur dioxide concentration, the burden and height of volcanic ash and dust, all of which pose a safety threat to aircraft. In addition, anomaly maps of many of AIRS standard products are being produced to help highlight "hot spots" and illustrate trends. To distribute it's applications imagery, AIRS is leveraging existing NASA data frameworks and organizations to facilitate archiving, distribution and participation in the BEDI. This poster will communicate the status of the applications effort for the AIRS Project and provide examples of new maps designed to best communicate the AIRS data.

  16. Assessment Applications of Ontologies.

    ERIC Educational Resources Information Center

    Chung, Gregory K. W. K.; Niemi, David; Bewley, William L.

    This paper discusses the use of ontologies and their applications to assessment. An ontology provides a shared and common understanding of a domain that can be communicated among people and computational systems. The ontology captures one or more experts' conceptual representation of a domain expressed in terms of concepts and the relationships…

  17. AUTOMATED INADVERTENT INTRUDER APPLICATION

    SciTech Connect

    Koffman, L; Patricia Lee, P; Jim Cook, J; Elmer Wilhite, E

    2007-05-29

    The Environmental Analysis and Performance Modeling group of Savannah River National Laboratory (SRNL) conducts performance assessments of the Savannah River Site (SRS) low-level waste facilities to meet the requirements of DOE Order 435.1. These performance assessments, which result in limits on the amounts of radiological substances that can be placed in the waste disposal facilities, consider numerous potential exposure pathways that could occur in the future. One set of exposure scenarios, known as inadvertent intruder analysis, considers the impact on hypothetical individuals who are assumed to inadvertently intrude onto the waste disposal site. Inadvertent intruder analysis considers three distinct scenarios for exposure referred to as the agriculture scenario, the resident scenario, and the post-drilling scenario. Each of these scenarios has specific exposure pathways that contribute to the overall dose for the scenario. For the inadvertent intruder analysis, the calculation of dose for the exposure pathways is a relatively straightforward algebraic calculation that utilizes dose conversion factors. Prior to 2004, these calculations were performed using an Excel spreadsheet. However, design checks of the spreadsheet calculations revealed that errors could be introduced inadvertently when copying spreadsheet formulas cell by cell and finding these errors was tedious and time consuming. This weakness led to the specification of functional requirements to create a software application that would automate the calculations for inadvertent intruder analysis using a controlled source of input parameters. This software application, named the Automated Inadvertent Intruder Application, has undergone rigorous testing of the internal calculations and meets software QA requirements. The Automated Inadvertent Intruder Application was intended to replace the previous spreadsheet analyses with an automated application that was verified to produce the same calculations and

  18. Novel Applications of Peroxidase

    NASA Astrophysics Data System (ADS)

    Rob, Abdul; Ball, Andrew S.; Tuncer, Munir; Wilson, Michael T.

    1997-02-01

    The article entitled "Novel Biocatalysts Will Work Even Better for Industry" published recently in this Journal (1) was informative and interesting. However it touched only briefly on the application of peroxidase as catalyst. Here, we would like to mention in more detail the novel applications of peroxidase in agricultural, paper pulp, water treatment, pharmaceutical, and medical situations. Firstly, the peroxidase isolated from Phanerochaete chyrosporium has been shown to detoxify herbicides such as atrazine to less toxic compounds and would certainly find potential application in agriculture (2). Secondly, the peroxidase produced by Streptomyces thermoviolaceus may find application in the paper pulp industry as a delignifying agent (3). Thirdly, it has been shown that extracellular peroxidase produced by Streptomyces avermitilis can remove the intense color from paper-mill effluent obtained after semichemical alkaline pulping of wheat straw (4), and thus this enzyme might find application as a catalyst in water treatment plants. Fourthly, the heme-containing horseradish peroxidase enzyme has been exploited in several diagnostic applications in pharmaceutics and medicine, such as the detection of human immunodeficiency virus and cystic fibrosis (5-10). Finally, recent work from our laboratory has suggested that thermophilic nonheme peroxidase produced by Thermomonospora fusca BD25 may find medical use in the diagnosis of myocardial infarction (11, 12). Literature Cited 1. Wiseman, A. J. Chem. Educ. 1996, 73, 55-58. 2. Mougin, C. Appl. Environ. Microbiol. 1994, 60, 705-708. 3. McCarthy A. J.; Peace, W.; Broda, P. Appl. Microbiol. Technol. 1985, 23, 238-244. 4. Hernandez, M; Rodriguez J; Soliveri, J; Copa, J. L; Perez, M. I; Arias, M. E. Appl. Environ. Microbiol. 1994, 60, 3909-3913. 5. Hopfer, S. M.; Aslanzadeh, J. Ann. Clin. Lab. Sci. 1995, 25, 475-480. 6. Suzuki, K; Iman, M. J. Virol. Methods 1995, 55, 347-356. 7. Nielsen, K. J. Immunoassay 1995, 16, 183-197. 8

  19. Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: a case study of breast cancer screening and diagnostic devices.

    PubMed

    Vreugdenburg, T D; Willis, C D; Mundy, L; Hiller, J E

    2013-01-01

    While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence. PMID:22032398

  20. Analysis of longitudinal laboratory data in the presence of common selection mechanisms: a view toward greater emphasis on pre-marketing pharmaceutical safety.

    PubMed

    Schildcrout, Jonathan S; Jenkins, Cathy A; Ostroff, Jack H; Gillen, Daniel L; Harrell, Frank E; Trost, Donald C

    2008-05-30

    Pharmaceutical safety has received substantial attention in the recent past; however, longitudinal clinical laboratory data routinely collected during clinical trials to derive safety profiles are often used ineffectively. For example, these data are frequently summarized by comparing proportions (between treatment arms) of participants who cross pre-specified threshold values at some time during follow-up. This research is intended, in part, to encourage more effective utilization of these data by avoiding unnecessary dichotomization of continuous data, acknowledging and making use of the longitudinal follow-up, and combining data from multiple clinical trials. However, appropriate analyses require careful consideration of a number of challenges (e.g. selection, comparability of study populations, etc.). We discuss estimation strategies based on estimating equations and maximum likelihood for analyses in the presence of three response history-dependent selection mechanisms: dropout, follow-up frequency, and treatment discontinuation. In addition, because clinical trials' participants usually represent non-random samples from target populations, we describe two sensitivity analysis approaches. All discussions are motivated by an analysis that aims to characterize the dynamic relationship between concentrations of a liver enzyme (alanine aminotransferase) and three distinct doses (no drug, low dose, and high dose) of an nk-1 antagonist across four Phase II clinical trials. PMID:17929332

  1. Magnetoplasmadynamic thruster applications

    NASA Technical Reports Server (NTRS)

    Pawlik, E. V.

    1976-01-01

    Advance study activities within NASA indicate that electric propulsion will be required to make certain types of potential missions feasible. The large power levels under consideration make magnetoplasmadynamic thrusters a good candidate for these applications since this type of electric thruster is best suited to operation at high power levels. This paper examines the status of the magnetoplasmadynamic thruster and compares it to the ion thruster which also is a candidate. The use of these two types of electric propulsion devices for orbit raising of a self-powered large satellite is examined from a cost standpoint. In addition the use of nuclear electric propulsion is described for use as both a near-earth space tug and for an interplanetary exploration vehicle. These preliminary examinations indicate that the magnetoplasmadynamic thruster is the lowest cost thruster and therefore merits serious consideration for these applications.

  2. Excilamps and their applications

    NASA Astrophysics Data System (ADS)

    Lomaev, M. I.; Sosnin, E. A.; Tarasenko, V. F.

    2012-01-01

    The design and practical applications of excilamps having a dielectric barrier and capacitive structure and driven by nanosecond, high voltage pulses are described. A simple design lamp having forced cooling and an excitation generator was demonstrated to have a lifetime of more than one thousand hours. The results of an experimental study of capacitive and high voltage nanosecond discharge-driven excilamps are presented. The influence of the excitation regime and operating gas mixture pressure on the dielectric barrier discharge (DBD) driven excilamps' efficiency is discussed. The discharge formation and output radiation dynamics of DBD driven excilamps was experimentally studied for the first time. The practical applications of several lamps designed in the High Current Electronics Institute, Tomsk, Russia to photochemistry, photobiology and photomedicine are discussed.

  3. Ceramics for fusion applications

    SciTech Connect

    Clinard, F.W. Jr.

    1986-01-01

    Ceramics are required for a variety of uses in both near-term fusion devices and in commercial powerplants. These materials must retain adequate structural and electrical properties under conditions of neutron, particle, and ionizing irradiation; thermal and applied stresses; and physical and chemical sputtering. Ceramics such as Al/sub 2/O/sub 3/, MgAl/sub 2/O/sub 4/, BeO, Si/sub 3/N/sub 4/ and SiC are currently under study for fusion applications, and results to date show widely-varying response to the fusion environment. Materials can be identified today which will meet initial operating requirements, but improvements in physical properties are needed to achieve satisfactory lifetimes for critical applications.

  4. RAIS PDA Application

    Energy Science and Technology Software Center (ESTSC)

    2004-10-06

    The Regulatory Authority Information System (RAIS) is a management tool for information related to the regulatory control of radioactive sealed sources developed for the International Atomic Energy Agency (IAEA). The RAIS PDA Application extends the functionality of the RAIS database by allowinig users to download radioactive sealed source data from the RAIS database to a portable PDA equipped with a barcode scanner. This allows users to verify radioactive sealed source data, gather radioactive sealed sourcemore » audit information, and upload audit data to the RAIS database in the field. The application was developed for a tested on the Symbol Model SPT 1800 PDA with PalmOS version 4.1 and a built-in barcode scanner.« less

  5. Applications of microvascular surgery.

    PubMed

    Miller, C W; Fowler, J D

    1990-09-01

    The advent of microvascular surgery has radically changed the discipline of human reconstructive surgery over the last decade. The ability to anastomose vessels less than 1 mm in diameter allows the distant transfer of tissues with a known blood supply from one area of the body to another. These tissues can be detached from their local blood supply and reperfused by anastomosing vessels supplying the tissue transfer to vessels near the recipient site. This technique has been used to transfer a variety of tissues and combinations of tissues including skin, muscle, bone, and bowel to solve a variety of difficult reconstructive problems. Applications, potential applications, and problems associated with microvascular free tissue transfer will be discussed in this chapter. PMID:2134600

  6. NASA: Biomedical applications team

    NASA Technical Reports Server (NTRS)

    1981-01-01

    The status of projects involving the adaptation of NASA technologies for medical purposes is reviewed. Devices for the measurement of joint deformation of arthritic hands, the development of an artificial pancreas, provision of an auditory signal to avert epileptic seizures, are described along with the control of medication levels, a compressed air tank to supply power for field dentistry, and an electroencephalogram monitor. The use of the Lixiscope as a portable fluoroscope, thermal laminates for hand and foot warmers for patients with Raynaud's syndrome, and the use of absorptive coatings for instruments for controlling medication levels are described. The applicability of occupation health and safety practices to industry, computerized patient scheduling, impregnation of the common facial tissue with an agent for killing respiratory viruses, commercial applications of anthropometric data, and multispectral image analysis of the skin as a diagnostic tool are reviewed.

  7. Nattokinase: production and application.

    PubMed

    Dabbagh, Fatemeh; Negahdaripour, Manica; Berenjian, Aydin; Behfar, Abdolazim; Mohammadi, Fatemeh; Zamani, Mozhdeh; Irajie, Cambyz; Ghasemi, Younes

    2014-11-01

    Nattokinase (NK, also known as subtilisin NAT) (EC 3.4.21.62) is one of the most considerable extracellular enzymes produced by Bacillus subtilis natto. The main interest about this enzyme is due to its direct fibrinolytic activity. Being stable enough in the gastrointestinal tract makes this enzyme a useful agent for the oral thrombolytic therapy. Thus, NK is regarded as a valuable dietary supplement or nutraceutical. Proven safety and ease of mass production are other advantages of this enzyme. In addition to these valuable advantages, there are other applications attributed to NK including treatment of hypertension, Alzheimer's disease, and vitreoretinal disorders. This review tends to bring a brief description about this valuable enzyme and summarizes the various biotechnological approaches used in its production, recovery, and purification. Some of the most important applications of NK, as well as its future prospects, are also discussed. PMID:25348469

  8. RAIS PDA Application

    SciTech Connect

    2004-10-06

    The Regulatory Authority Information System (RAIS) is a management tool for information related to the regulatory control of radioactive sealed sources developed for the International Atomic Energy Agency (IAEA). The RAIS PDA Application extends the functionality of the RAIS database by allowinig users to download radioactive sealed source data from the RAIS database to a portable PDA equipped with a barcode scanner. This allows users to verify radioactive sealed source data, gather radioactive sealed source audit information, and upload audit data to the RAIS database in the field. The application was developed for a tested on the Symbol Model SPT 1800 PDA with PalmOS version 4.1 and a built-in barcode scanner.

  9. Remifentanil: applications in neonates.

    PubMed

    Kamata, Mineto; Tobias, Joseph D

    2016-06-01

    Remifentanil is a synthetic opioid derivative that was introduced into clinical practice in the United States in 1996. The unique modification of its chemical structure to include a methyl-ester ring allows its hydrolysis by non-specific plasma and tissue esterases. This molecular configuration results in its rapid metabolism thereby providing a rapid onset, easy titration by continuous infusion, and a short context-sensitive half-life with rapid elimination. These principles are stable and consistent across all age groups regardless of the infusion characteristics. Owing to these pharmacokinetic characteristics, it is an effective agent in the neonatal population allowing the provision of intense analgesia and anesthesia with a rapid recovery profile in various clinical scenarios. Here, we review the pharmacokinetics of remifentanil in neonates, discuss its clinical applications including intraoperative administration for anesthetic care, unique applications for procedural sedation including endotracheal intubation, and its potential use for sedation in the Intensive Care Unit setting during mechanical ventilation. PMID:26758072

  10. Newton polyhedron and applications

    SciTech Connect

    Bruno, A.D.

    1994-12-31

    We give a simple presentation of an algorithm of selecting asymptotical first approximations of equations (algebraic and ordinary differential and partial differential). Here the first approximation of a solution of the initial equation is a solution of the corresponding first approximation of the equation. The algorithm is based on the geometry of power exponents including the Newton polyhedron. We give also a survey of applications of the algorithm in problems of Celestial Mechanics and Hydrodynamics.

  11. Applications of ionic liquids.

    PubMed

    Patel, Divia Dinesh; Lee, Jong-Min

    2012-06-01

    Ionic liquids have recently gained popularity in the scientific community owing to their special properties and characteristics. One of the reasons why ionic liquids have been termed "green solvents" is due to their negligible vapour pressure. Their use in electrochemical, biological and metal extraction applications is discussed. Wide research has been carried out for their use in batteries, solar panels, fuel cells, drug deliveries and biomass pretreatments. This work aims to consolidate the various findings from previous works in these areas. PMID:22711528

  12. Neural network applications

    NASA Technical Reports Server (NTRS)

    Padgett, Mary L.; Desai, Utpal; Roppel, T.A.; White, Charles R.

    1993-01-01

    A design procedure is suggested for neural networks which accommodates the inclusion of such knowledge-based systems techniques as fuzzy logic and pairwise comparisons. The use of these procedures in the design of applications combines qualitative and quantitative factors with empirical data to yield a model with justifiable design and parameter selection procedures. The procedure is especially relevant to areas of back-propagation neural network design which are highly responsive to the use of precisely recorded expert knowledge.

  13. AGU membership applications

    NASA Astrophysics Data System (ADS)

    Applications for membership have been received from the following individuals. The letter after the name denotes the proposed primary section affiliation.Raffi Aroian (P), David Baker (P), D. Craig Barilotti (O), Stephen J. Barnes (V), Thomas O. Barnwell (H), Robert P. Bessette (G), Brian Bicknell (H), William Blumberg (A), Michele A. Boccadoro (G), Richard Boylan (T), Robert C. Bucknam (T), Roman J. Budzianowski (H), Bruce M. Crowe (V), Charles G. Cunningham (V).

  14. Baltimore applications project

    NASA Technical Reports Server (NTRS)

    Golden, T. S.; Yaffee, P.

    1978-01-01

    The Baltimore Applications Project (BAP) was originally designed as an experimental effort to assist the government of the City of Baltimore in applying technology to the solution of municipal problems. Recent modifications in the structuring and operation of the program are discussed. A tabular update on the individual tasks undertaken and their treatment is provided. Details of energy and nonenergy related tasks are presented in appendices.

  15. AGU membership applications

    NASA Astrophysics Data System (ADS)

    Applications for membership have been received from the following individuals. The letter after the name denotes the proposed primary section affiliation.Aubrey L. Anderson (O), Lennart A. Anderson (V), Kathleen W. Baird (V), William R. Bergmann (A), E. N. Bernard (O), Joyce R. Blueford (O), Wayne M. Brewer (T), Nancy Ann Brewster (O), Philip S. Callahan (O), Jack G. Calvert (A), Drew A. Carey (O), Benjamin Chen (O), J. W. Cole (V), George Courtney (T), Charles G. Crawford (H).

  16. Advanced Welding Applications

    NASA Technical Reports Server (NTRS)

    Ding, Robert J.

    2010-01-01

    Some of the applications of advanced welding techniques are shown in this poster presentation. Included are brief explanations of the use on the Ares I and Ares V launch vehicle and on the Space Shuttle Launch vehicle. Also included are microstructural views from four advanced welding techniques: Variable Polarity Plasma Arc (VPPA) weld (fusion), self-reacting friction stir welding (SR-FSW), conventional FSW, and Tube Socket Weld (TSW) on aluminum.

  17. Laser applications in criminalistics

    NASA Astrophysics Data System (ADS)

    Menzel, E. R.

    1990-10-01

    Lasers find application in numerous areas of criminalistics such as fiber analysis document examination and serology. Their widest use however is in detection of latent finger prints. Several routine procedures for obtaining laserexcited fingerprint fluorescence on a range of surfaces have been devel oped. However many surfaces fluoresce so strongly themselves that they are not amenable to these procedures. Timeresolved luminescence imaging is being investigated to permit detection of fingerprints on such surfaces.

  18. ARM for Platform Application

    NASA Astrophysics Data System (ADS)

    Patte, Mathieu; Poupat, Jean-Luc; Le Meur, Patrick

    2015-09-01

    The activities described in this paper are part of the CNES R&T “Study of a Cortex-R ARM based architecture” performed by Airbus DS Space System & Electronics in 2014. With the support of CNES, Airbus DS has performed the porting of a representative space application software on an ARM based demonstration platform. This paper presents the platform itself, the activities performed at software level and the first results on this evaluation study.

  19. Performance Application Programming Interface

    Energy Science and Technology Software Center (ESTSC)

    2005-10-31

    PAPI is a programming interface designed to provide the tool designer and application engineer with a consistent interface and methodology for use of the performance counter hardware found in most major microprocessors. PAPI enables software engineers to see, in near real time, the relation between software performance and processor events. This release covers the hardware dependent implementation of PAPI version 3 for the IBM BlueGene/L (BG/L) system.

  20. Opportunities for PV applications

    NASA Technical Reports Server (NTRS)

    Scott-Monck, John A.; Rahilly, W. Patrick

    1987-01-01

    Workshop members devoted the majority of time to discussing future prospects for technology support of photovoltaic applications. Photovoltaics has provided power for almost every spacecraft launched in the free world in the last 25 years. Over this time, photovoltaics has demonstrated impressive growth in power level, operating lifetime and specific power (W/kg and W/square m). Yet, the current attitude toward this reliable form of space power generation is likely to preclude further dramatic performance gains.

  1. Meteorological image processing applications

    NASA Technical Reports Server (NTRS)

    Bracken, P. A.; Dalton, J. T.; Hasler, A. F.; Adler, R. F.

    1979-01-01

    Meteorologists at NASA's Goddard Space Flight Center are conducting an extensive program of research in weather and climate related phenomena. This paper focuses on meteorological image processing applications directed toward gaining a detailed understanding of severe weather phenomena. In addition, the paper discusses the ground data handling and image processing systems used at the Goddard Space Flight Center to support severe weather research activities and describes three specific meteorological studies which utilized these facilities.

  2. QMRPACK and applications

    SciTech Connect

    Freund, R.W.; Nachtigal, N.M.

    1994-10-01

    QMRPACK is a package of quasi-minimal residual algorithms for the iterative solution of linear systems. In this paper, the authors describe the main features of QMRPACK, comment on the implementations found in the package, and discuss how they would be invoked in a user code. They briefly describe two applications of the codes in the area of simulation of material properties from first principles, and in circuit simulation. They conclude by presenting future directions for QMRPACK.

  3. Fuel cell market applications

    SciTech Connect

    Williams, M.C.

    1995-12-31

    This is a review of the US (and international) fuel cell development for the stationary power generation market. Besides DOE, GRI, and EPRI sponsorship, the US fuel cell program has over 40% cost-sharing from the private sector. Support is provided by user groups with over 75 utility and other end-user members. Objectives are to develop and demonstrate cost-effective fuel cell power generation which can initially be commercialized into various market applications using natural gas fuel by the year 2000. Types of fuel cells being developed include PAFC (phosphoric acid), MCFC (molten carbonate), and SOFC (solid oxide); status of each is reported. Potential international applications are reviewed also. Fuel cells are viewed as a force in dispersed power generation, distributed power, cogeneration, and deregulated industry. Specific fuel cell attributes are discussed: Fuel cells promise to be one of the most reliable power sources; they are now being used in critical uninterruptible power systems. They need hydrogen which can be generated internally from natural gas, coal gas, methanol landfill gas, or other fuels containing hydrocarbons. Finally, fuel cell development and market applications in Japan are reviewed briefly.

  4. Transactional Network Platform: Applications

    SciTech Connect

    Katipamula, Srinivas; Lutes, Robert G.; Ngo, Hung; Underhill, Ronald M.

    2013-10-31

    In FY13, Pacific Northwest National Laboratory (PNNL) with funding from the Department of Energy’s (DOE’s) Building Technologies Office (BTO) designed, prototyped and tested a transactional network platform to support energy, operational and financial transactions between any networked entities (equipment, organizations, buildings, grid, etc.). Initially, in FY13, the concept demonstrated transactions between packaged rooftop air conditioners and heat pump units (RTUs) and the electric grid using applications or "agents" that reside on the platform, on the equipment, on a local building controller or in the Cloud. The transactional network project is a multi-lab effort with Oakridge National Laboratory (ORNL) and Lawrence Berkeley National Laboratory (LBNL) also contributing to the effort. PNNL coordinated the project and also was responsible for the development of the transactional network (TN) platform and three different applications associated with RTUs. This document describes two applications or "agents" in details, and also summarizes the platform. The TN platform details are described in another companion document.

  5. Applications of electrostatic accelerators

    SciTech Connect

    Norton, G.A.; Klody, G.M.

    1995-10-01

    Most applications of electrostatic accelerators fit into two main groups, materials analysis and materials modification. Materials analysis includes routine use of Rutherford Backscattering for quality control applications in the semiconductor field. Particle induced x-ray emission (PDCE) is used in fields from art history through environmental sciences. X-ray imaging using 5 MeV DC electron beams and fast pulsed neutron analysis (PFNA) for plastic explosive and drug detection provide promise in the area of security. Accelerator based mass spectrometry (AMS) is having a profound effect in a wide variety of fields which rely on counting extremely rare isotopes in small samples. Materials modification provides a very significant economic impact in the field of semiconductors. Virtually all semiconductor devices now rely on ion implantation with ion beam energies ranging from a few kilovolts to several MeV. With some mention of electron beams, this talk will concentrate primarily on the applications of MeV ion beams from electrostatic accelerators.

  6. IMS applications analysis

    SciTech Connect

    RODACY,PHILIP J.; REBER,STEPHEN D.; SIMONSON,ROBERT J.; HANCE,BRADLEY G.

    2000-03-01

    This report examines the market potential of a miniature, hand-held Ion Mobility Spectrometer. Military and civilian markets are discussed, as well as applications in a variety of diverse fields. The strengths and weaknesses of competing technologies are discussed. An extensive Ion Mobility Spectrometry (IMS) bibliography is included. The conclusions drawn from this study are: (1) There are a number of competing technologies that are capable of detecting explosives, drugs, biological, or chemical agents. The IMS system currently represents the best available compromise regarding sensitivity, specificity, and portability. (2) The military market is not as large as the commercial market, but the military services are more likely to invest R and D funds in the system. (3) Military applications should be addressed before commercial applications are addressed. (4) There is potentially a large commercial market for rugged, hand-held Ion Mobility Spectrometer systems. Commercial users typically do not invest R and D funds in this type of equipment rather, they wait for off-the-shelf availability.

  7. Next generation EFB applications

    NASA Astrophysics Data System (ADS)

    Pschierer, C.; Sindlinger, A.; Barraci, N.; Wiesemann, T.; Gaertner, M.; Schiefele, J.

    2011-06-01

    Today pilots have to obtain required information from a number of different sources like airport/SID/STAR/approach or enroute charts (respectively their electronic representations), printouts like the flight plan or a weather briefing, and updates via voice communications. The flight crew is required to mentally combine all this information. This situation will become even more difficult to cope with in the SESAR/NextGen world with dynamic changes of the trajectory (flight plan), and more frequent updates of weather, NOTAMs and other information requiring a higher degree of automation and better information presentation. To address these issues, lower the pilot's workload, and increase his situational awareness, a concept is presented where all required information is provided through one application. Depending on the phase of flight (taxi-in/taxi-out, departure, enroute, arrival, approach) the application will select the currently required information and provide a seamless representation for the crew. The challenge is to provide the right information at the right time to the crew (e.g. significant weather moving into the direction of the flight plan). The focus of this paper will be on the components of the new application related to ground operations. This includes an enhanced, AMM-like view with integrated taxi-routing support, graphical and textual display of chart notes (e.g. wingspan restrictions, taxiway closures etc.), and updates of such information by automatic inclusion of digital NOTAMs.

  8. Panoramic lens applications revisited

    NASA Astrophysics Data System (ADS)

    Thibault, Simon

    2008-04-01

    During the last few years, innovative optical design strategies to generate and control image mapping have been successful in producing high-resolution digital imagers and projectors. This new generation of panoramic lenses includes catadioptric panoramic lenses, panoramic annular lenses, visible/IR fisheye lenses, anamorphic wide-angle attachments, and visible/IR panomorph lenses. Given that a wide-angle lens images a large field of view on a limited number of pixels, a systematic pixel-to-angle mapping will help the efficient use of each pixel in the field of view. In this paper, we present several modern applications of these modern types of hemispheric lenses. Recently, surveillance and security applications have been proposed and published in Security and Defence symposium. However, modern hemispheric lens can be used in many other fields. A panoramic imaging sensor contributes most to the perception of the world. Panoramic lenses are now ready to be deployed in many optical solutions. Covered applications include, but are not limited to medical imaging (endoscope, rigiscope, fiberscope...), remote sensing (pipe inspection, crime scene investigation, archeology...), multimedia (hemispheric projector, panoramic image...). Modern panoramic technologies allow simple and efficient digital image processing and the use of standard image analysis features (motion estimation, segmentation, object tracking, pattern recognition) in the complete 360° hemispheric area.

  9. [The applicability of results].

    PubMed

    Marín-León, I

    2015-11-01

    The ultimate aim of the critical reading of medical literature is to use the scientific advances in clinical practice or for innovation. This requires an evaluation of the applicability of the results of the studies that have been published, which begins with a clear understanding of these results. When the studies do not provide sufficient guarantees of rigor in design and analysis, the conditions necessary for the applicability of the results are not met; however, the fact that the results are reliable is not enough to make it worth trying to use their conclusions. This article explains how carrying out studies in experimental or artificial conditions often moves them away from the real conditions in which they claim to apply their conclusions. To evaluate this applicability, the article proposes evaluating a set of items that will enable the reader to determine the likelihood that the benefits and risks reported in the studies will yield the least uncertainty in the clinical arena where they aim to be applied. PMID:26454562

  10. FPA Depot - Web Application

    NASA Technical Reports Server (NTRS)

    Avila, Edwin M. Martinez; Muniz, Ricardo; Szafran, Jamie; Dalton, Adam

    2011-01-01

    Lines of code (LOC) analysis is one of the methods used to measure programmer productivity and estimate schedules of programming projects. The Launch Control System (LCS) had previously used this method to estimate the amount of work and to plan development efforts. The disadvantage of using LOC as a measure of effort is that one can only measure 30% to 35% of the total effort of software projects involves coding [8]. In the application, instead of using the LOC we are using function point for a better estimation of hours in each software to develop. Because of these disadvantages, Jamie Szafran of the System Software Branch of Control And Data Systems (NE-C3) at Kennedy Space Canter developed a web application called Function Point Analysis (FPA) Depot. The objective of this web application is that the LCS software architecture team can use the data to more accurately estimate the effort required to implement customer requirements. This paper describes the evolution of the domain model used for function point analysis as project managers continually strive to generate more accurate estimates.

  11. Load Balancing Scientific Applications

    SciTech Connect

    Pearce, Olga Tkachyshyn

    2014-12-01

    The largest supercomputers have millions of independent processors, and concurrency levels are rapidly increasing. For ideal efficiency, developers of the simulations that run on these machines must ensure that computational work is evenly balanced among processors. Assigning work evenly is challenging because many large modern parallel codes simulate behavior of physical systems that evolve over time, and their workloads change over time. Furthermore, the cost of imbalanced load increases with scale because most large-scale scientific simulations today use a Single Program Multiple Data (SPMD) parallel programming model, and an increasing number of processors will wait for the slowest one at the synchronization points. To address load imbalance, many large-scale parallel applications use dynamic load balance algorithms to redistribute work evenly. The research objective of this dissertation is to develop methods to decide when and how to load balance the application, and to balance it effectively and affordably. We measure and evaluate the computational load of the application, and develop strategies to decide when and how to correct the imbalance. Depending on the simulation, a fast, local load balance algorithm may be suitable, or a more sophisticated and expensive algorithm may be required. We developed a model for comparison of load balance algorithms for a specific state of the simulation that enables the selection of a balancing algorithm that will minimize overall runtime.

  12. Electrospinning and its applications

    NASA Astrophysics Data System (ADS)

    Park, Jun-Seo

    2010-12-01

    Electrospinning is a process used to fabricate continuous nanoscale fibers with diameters in the sub-micrometer to nanometer range using a high-voltage power supply. Electrospun (e-spun) fibers and the non-woven webs manufactured from them have attracted considerable attention due to their outstanding characteristics, such as high porosity, small diameter, excellent pore interconnectivity and high surface-to-volume ratio. Because of the useful properties of e-spun fibers, many synthetic and natural polymers, including single and blended polymers, have been electrospun into fibers that can be employed in a variety of applications such as filtration and thermal insulation, and in the manufacture of protective clothing, sensors, conducting devices, wound dressings and scaffolds for tissue engineering. Utilizing the electrospinning technique and its product, some studies on its applications have been conducted in our lab. They included the fabrication of a conducting composite mat for electrical applications, an antibacterial web for a biomedical sector and PCM containing e-spun mat for energy storage.

  13. Commercial applications for COIL

    NASA Astrophysics Data System (ADS)

    Solomon, Wayne C.; Carroll, David L.; King, D. M.; Fockler, L. A.; Stromberg, D. S.; Sexauer, M.; Milmoe, A.; Sentman, Lee H.

    2000-01-01

    The chemical oxygen-iodine laser (COIL) is a high power, fiber deliverable tool, which can be used for a number of different industrial applications. COIL is of particular interest because of its short fiber deliverable wavelength, high scaleable continuous wave power, and excellent material interaction properties. In past research the University of Illinois at Urbana-Champaign identified and decommissioning and decontamination (DD) of nuclear facilities as a primary focus for COIL technology. DD will be a major challenge in the coming decades. The use of a robotically driven fiber delivered cutting/ablation tool in contaminated areas promises to lower risks to workers for the DD mission. Further, the high cutting speed of COIL will significantly reduce the time required to cut contaminated equipment, reducing costs. The high power of COIL will permit the dismantling of thick stacks of piping and equipment as well as reactor vessels. COIL is very promising for the removal of material from contaminated surfaces, perhaps to depths thicker than an inch. Laser cutting and ablation minimizes dust and fumes, which reduces the required number of high efficiency particulate accumulator filters, thus reducing costly waste disposal. Other potential industrial applications for COIL are shipbuilding, automotive manufacturing, heavy machinery manufacturing, tasks requiring underwater cutting or welding, and there appear to be very promising applications for high powers lasers in the oil industry.

  14. Application Program Interface for Engineering and Scientific Applications

    Energy Science and Technology Software Center (ESTSC)

    2001-10-18

    An Application Program Interface (API) for engineering and scientific applications. This system allows application developers to write to a single uniform interface, obtaining access to all solvers in the Trilinos framwork. This includes linear solvers, eigensolvers, non-linear solvers, and time-dependent solvers.

  15. 40 CFR 194.15 - certification application(s).

    Code of Federal Regulations, 2010 CFR

    1996-07-01

    ... ISOLATION PILOT PLANT'S COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS Compliance Certification and Re-certification Applications Sec. 194.15 Content of compliance re-certification application(s... Sec. 194.15 Content of compliance re PROTECTION OF ENVIRONMENT ENVIRONMENTAL PROTECTION...

  16. International Space Station Environmental Control and Life Support System: Verification for the Pressurized Mating Adapters

    NASA Technical Reports Server (NTRS)

    Williams, David E.

    2007-01-01

    The International Space Station (ISS) Pressurized Mating Adapters (PMAs) Environmental Control and Life Support (ECLS) System is comprised of three subsystems: Atmosphere Control and Supply (ACS), Temperature and Humidity Control (THC), and Water Recovery and Management (WRM). PMA 1 and PMA 2 flew to ISS on Flight 2A and PMA 3 flew to ISS on Flight 3A. This paper provides a summary of the PMAs ECLS design and the detailed Element Verification methodologies utilized during the Qualification phase for the PMAs.

  17. LAVA Applications to Open Rotors

    NASA Technical Reports Server (NTRS)

    Kiris, Cetin C.; Housman, Jeff; Barad, Mike; Brehm, Christoph

    2015-01-01

    Outline: LAVA (Launch Ascent Vehicle Aerodynamics); Introduction; Acoustics Related Applications; LAVA Applications to Open Rotor; Structured Overset Grids; Cartesian Grid with Immersed Boundary; High Speed Case; High Speed Case with Plate Low Speed Case.

  18. Applications of lobster eye optics

    NASA Astrophysics Data System (ADS)

    Hudec, R.; Pina, L.; Inneman, A.; Tichy, V.

    2015-05-01

    Applications of wide field Lobster Eye X ray telescopes are presented and discussed. The wide field X ray optics was originally proposed for use in X-ray astronomy, but there are numerous other application areas as well.

  19. Sample Cancer Epidemiology Grant Applications

    Cancer.gov

    The National Cancer Institute frequently receives questions from investigators for examples of successfully funded grant applications. Several investigators agreed to let the Epidemiology and Genomics Research Program post excerpts of their grant applications online.

  20. Capacitor Technologies, Applications and Reliability

    NASA Technical Reports Server (NTRS)

    1981-01-01

    Various aspects of capacitor technologies and applications are discussed. Major emphasis is placed on: the causes of failures; accelerated testing; screening tests; destructive physical analysis; applications techniques; and improvements in capacitor capabilities.

  1. 76 FR 37895 - Merger Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-28

    ... Office of Thrift Supervision Merger Applications AGENCY: Office of Thrift Supervision (OTS), Treasury... collection. Title of Proposal: Merger Applications. OMB Number: 1550-0016. Form Number: N/A. Description: No savings association may, without application to and approval by the OTS combine with any...

  2. Liquid lubrication for space applications

    NASA Technical Reports Server (NTRS)

    Fusaro, Robert L.; Khonsari, Michael M.

    1992-01-01

    Reviewed here is the state of the art of liquid lubrication for space applications. The areas discussed are types of liquid lubrication mechanisms, space environmental effects on lubrication, classification of lubricants, liquid lubricant additives, grease lubrication, mechanism materials, bearing anomalies and failures, lubricant supply techniques, and application types and lubricant needs for those applications.

  3. Systems Applications in Higher Education.

    ERIC Educational Resources Information Center

    Schure, Alexander

    This paper discusses the application of computers for higher education and describes a philosophy and initial application of an accountability system that can aid in coping with the problems of occupationally related schools. Discussed are: (1) the role of computers in systems application; (2) the need for systems related information: the…

  4. The applicability of Jeans rule.

    NASA Astrophysics Data System (ADS)

    Chongyi, Gao

    1997-10-01

    Jeans rule has a wide applicability. It is not only applicable for the planets and satellites in the solar system, but also suitable for the asteroids, meteoroids and the unusual outer solar system object 95P/Chiron. Its applicability can be expressed with a nomogram as well as defined by equations or by figures.

  5. Radar applications overview

    NASA Astrophysics Data System (ADS)

    Greenspan, Marshall

    1996-06-01

    During the fifty years since its initial development as a means of providing early warning of airborne attacks against allied countries during World War II, radar systems have developed to the point of being highly mobile and versatile systems capable of supporting a wide variety of remote sensing applications. Instead of being tied to stationary land-based sites, radar systems have found their way into highly mobile land vehicles as well as into aircraft, missiles, and ships of all sizes. Of all these applications, however, the most exciting revolution has occurred in the airborne platform arena where advanced technology radars can be found in all shapes and sizes...ranging from the large AWACS and Joint STARS long range surveillance and targeting systems to small millimeter wave multi-spectral sensors on smart weapons that can detect and identify their targets through the use of highly sophisticated digital signal processing hardware and software. This paper presents an overview of these radar applications with the emphasis on modern airborne sensors that span the RF spectrum. It will identify and describe the factors that influence the parameters of low frequency and ultra wide band radars designed to penetrate ground and dense foliage environments and locate within them buried mines, enemy armor, and other concealed or camouflaged weapons of war. It will similarly examine the factors that lead to the development of airborne radar systems that support long range extended endurance airborne surveillance platforms designed to detect and precision-located both small high speed airborne threats as well as highly mobile time critical moving and stationary surface vehicles. The mission needs and associated radar design impacts will be contrasted with those of radar systems designed for high maneuverability rapid acquisition tactical strike warfare platforms, and shorter range cued air-to-surface weapons with integral smart radar sensors.

  6. Biomedical applications of nisin.

    PubMed

    Shin, J M; Gwak, J W; Kamarajan, P; Fenno, J C; Rickard, A H; Kapila, Y L

    2016-06-01

    Nisin is a bacteriocin produced by a group of Gram-positive bacteria that belongs to Lactococcus and Streptococcus species. Nisin is classified as a Type A (I) lantibiotic that is synthesized from mRNA and the translated peptide contains several unusual amino acids due to post-translational modifications. Over the past few decades, nisin has been used widely as a food biopreservative. Since then, many natural and genetically modified variants of nisin have been identified and studied for their unique antimicrobial properties. Nisin is FDA approved and generally regarded as a safe peptide with recognized potential for clinical use. Over the past two decades the application of nisin has been extended to biomedical fields. Studies have reported that nisin can prevent the growth of drug-resistant bacterial strains, such as methicillin-resistant Staphylococcus aureus, Streptococcus pneumoniae, Enterococci and Clostridium difficile. Nisin has now been shown to have antimicrobial activity against both Gram-positive and Gram-negative disease-associated pathogens. Nisin has been reported to have anti-biofilm properties and can work synergistically in combination with conventional therapeutic drugs. In addition, like host-defence peptides, nisin may activate the adaptive immune response and have an immunomodulatory role. Increasing evidence indicates that nisin can influence the growth of tumours and exhibit selective cytotoxicity towards cancer cells. Collectively, the application of nisin has advanced beyond its role as a food biopreservative. Thus, this review will describe and compare studies on nisin and provide insight into its future biomedical applications. PMID:26678028

  7. New emerging MEMS applications

    NASA Astrophysics Data System (ADS)

    Mounier, Eric; Eloy, Jean-Christophe

    2007-02-01

    This paper presents the trends for the years to come for the different MEMS markets. Consumer applications have really started to push the MEMS business in 2005. Many different devices are involved, like pressure sensors (altimeters), microphones, accelerometers, gyroscopes . . . One of the most significant consequences is that all the Top 50 semiconductor companies are now looking at these MEMS applications as possible growth areas. Another result of the growth of the MEMS market is the strong growth of the foundries and contract manufacturers. We have seen growth of more than 35% in 2005 compared to 2004 and we expect similar growth in the next 3 years. We will review the next MEMS applications which have currently a high growth: Si microphones, microdisplays (for RPTV, portable projectors or automotive HUDs), gyroscopes and micro-fuel cells. In the longer term, micro-source of energy could also become an important MEMS market. In term of milestones, the following points can be highlighted: -In 2005 market, the MEMS market is 5.1 B worldwide and very fragmented in terms of companies and products. -In 2010, it will be a 9.7 B market worldwide. MEMS foundries and contract manufacturers will account for at least 8 % of the world market with several being public companies. More than 50% of today's systems companies who have integrated fabs will be using external manufacturers. Several large integrated companies will have created independent MEMS spin-offs and IC manufacturers will be deeply involved in MEMS manufacturing. -In 2015, it will be an 18 B$ market worldwide with no longer systems manufacturers with internal fabs. And we forecast that 50% of the total market will be in the hands of semiconductor manufacturers.

  8. Factsheets Web Application

    SciTech Connect

    VIGIL,FRANK; REEDER,ROXANA G.

    2000-10-30

    The Factsheets web application was conceived out of the requirement to create, update, publish, and maintain a web site with dynamic research and development (R and D) content. Before creating the site, a requirements discovery process was done in order to accurately capture the purpose and functionality of the site. One of the high priority requirements for the site would be that no specialized training in web page authoring would be necessary. All functions of uploading, creation, and editing of factsheets needed to be accomplished by entering data directly into web form screens generated by the application. Another important requirement of the site was to allow for access to the factsheet web pages and data via the internal Sandia Restricted Network and Sandia Open Network based on the status of the input data. Important to the owners of the web site would be to allow the published factsheets to be accessible to all personnel within the department whether or not the sheets had completed the formal Review and Approval (R and A) process. Once the factsheets had gone through the formal review and approval process, they could then be published both internally and externally based on their individual publication status. An extended requirement and feature of the site would be to provide a keyword search capability to search through the factsheets. Also, since the site currently resides on both the internal and external networks, it would need to be registered with the Sandia search engines in order to allow access to the content of the site by the search engines. To date, all of the above requirements and features have been created and implemented in the Factsheet web application. These have been accomplished by the use of flat text databases, which are discussed in greater detail later in this paper.

  9. Industrial application experiment series

    NASA Technical Reports Server (NTRS)

    Bluhm, S. A.

    1981-01-01

    Two procurements within the Industrial Application Experiment Series of the Thermal Power Systems Project are discussed. The first procurement, initiated in April 1980, resulted in an award to the Applied Concepts Corporation for the Capital Concrete Experiment: two Fresnel concentrating collectors will be evaluated in single-unit installations at the Jet Propulsion Laboratory Parabolic Dish Test Site and at Capitol Concrete Products, Topeka, Kansas. The second procurement, initiated in March 1981, is titled, "Thermal System Engineering Experiment B." The objective of the procurement is the rapid deployment of developed parabolic dish collectors.

  10. Applications of spherical shells

    NASA Technical Reports Server (NTRS)

    Wang, T. G.

    1985-01-01

    A new technique of producing hollow spheres of many materials at a very rapid rate, at very low cost, and with high reproducibility of shell diameter and wall thickness has been developed. Shells formed of metal or of other solid materials are expected to find numerous technical and industrial applications. For example, metal shells might be used as inertial confinement fusion targets, or as the principal constituents in lightweight structural materials for NASA Space Stations or DOD large antennas and mirrors, or be employed as containers for phase-change heat-storage media, or serve as containers for hazardous materials, or be employed as catalytic surface agents.

  11. Mechanics: Ideas, problems, applications

    NASA Astrophysics Data System (ADS)

    Ishlinskii, A. Iu.

    The book contains the published articles and reports by academician Ishlinskii which deal with the concepts and ideas of modern mechanics, its role in providing a general understanding of the natural phenomena, and its applications to various problems in science and engineering. Attention is given to the methodological aspects of mechanics, to the history of the theories of plasticity, friction, gyroscopic and inertial systems, and inertial navigation, and to mathematical methods in mechanics. The book also contains essays on some famous scientists and engineers.

  12. Evaluating land application effects

    SciTech Connect

    Sarkis, K. )

    1987-01-01

    The Philadelphia, PA Water Department embarked on a land application program of its treated wastewater sludge in 1977. Initially, liquid sludge averaging from 1-5% solids was applied to approximately 400 acres of corn, soybeans, and sod at rates sufficient to supply crop nitrogen needs. During the 1978 through 1984 growing seasons, crops and soils were monitored for heavy metals (bioavailability of cadmium, copper, nickel, chromium, lead and zinc) and in 1984 for PCB accumulation. This report summarizes results of the monitoring program until 1984.

  13. Organic LED system applications

    NASA Astrophysics Data System (ADS)

    Cropper, A. D.; Cok, Ronald S.; Feldman, Rodney D.

    2001-02-01

    Organic LED (OLED) technology promises superior performance in brightness and color resolution, wider viewing angles, lower power consumption, thin displays, and robust physical characteristics. These advantages make OLED displays attractive for next-generation flat panel displays. This paper describes the state-of-the-art in OLED technology and addresses some of the benefits and difficulties facing the integration of OLED devices into a range of imaging equipment applications. We will review OLED performance from a systems perspective and will compare it to OLED material and panel properties. We will also describe the competitive attributes of a flat panel display and recent work done at Kodak on interfacing to OLED devices.

  14. NASA RFID Applications

    NASA Technical Reports Server (NTRS)

    Fink, Patrick, Ph.D.; Kennedy, Timothy, Ph.D; Powers, Anne; Haridi, Yasser; Chu, Andrew; Lin, Greg; Yim, Hester; Byerly, Kent, Ph.D.; Barton, Richard, Ph.D.; Khayat, Michael, Ph.D.; Studor, George; Brocato, Robert; Ngo, Phong; Arndt, G. D., Ph.D.; Gross, Julia; Phan, Chau; Ni, David, Ph.D.; Dusl, John; Dekome, Kent

    2007-01-01

    This viewgraph document reviews some potential uses for Radio Frequency Identification in space missions. One of these is inventory management in space, including the methods used in Apollo, the Space Shuttle, and Space Station. The potential RFID uses in a remote human outpost are reviewed. The use of Ultra-Wideband RFID for tracking are examined such as that used in Sapphire DART The advantages of RFID in passive, wireless sensors in NASA applications are shown such as: Micrometeoroid impact detection and Sensor measurements in environmental facilities The potential for E-textiles for wireless and RFID are also examined.

  15. Introduction to Medical Applications

    NASA Astrophysics Data System (ADS)

    Welch, Ashley J.; van Gemert, Martin J. C.

    The first two parts of this book describe various theories associated with light propagation in tissue and the resulting response. If coherence or polarization information is not needed, we assume that the transport equation governs the optical interaction of light with tissue and the heat conduction equation provides the basis for estimating the thermal response of tissue to laser radiation. In part III of this book, the theory for optical and thermal interactions of laser light with tissue are used to analyze medical applications. In particular, the concepts of parts I and II

  16. Programmable Logic Application Notes

    NASA Technical Reports Server (NTRS)

    Katz, Richard

    1999-01-01

    This column will be provided each quarter as a source for reliability, radiation results, NASA capabilities, and other information on programmable logic devices and related applications. This quarter the focus is on some experimental data on low voltage drop out regulators to support mixed 5 and 3.3 volt systems. A discussion of the Small Explorer WIRE spacecraft will also be given. Lastly, we show take a first look at robust state machines in Hardware Description Languages (VHDL) and their use in critical systems. If you have information that you would like to submit or an area you would like discussed or researched, please give me a call or e-mail.

  17. Composite prepreg application device

    NASA Technical Reports Server (NTRS)

    Sandusky, Donald A. (Inventor); Marchello, Joseph M. (Inventor)

    1996-01-01

    A heated shoe and cooled pressure roller assembly for composite prepreg application is provided. The shoe assembly includes a heated forward contact surface having a curved pressure surface. The following cooled roller provides a continuous pressure to the thermoplastic while reducing the temperature to approximately 5.degree. C. below glass transition temperature. Electric heating coils inside the forward portion of the shoe heat a thermoplastic workpiece to approximately 100.degree. C. above the glass transition. Immediately following the heated contact surface, a cooled roller cools the work. The end sharpened shape of the heated shoe trailing edge tends to prevent slag buildup and maintain a uniform, relaxed stress fabrication.

  18. Energy systems and applications

    SciTech Connect

    Not Available

    1983-01-01

    The Institute of Gas Technology (IGT) Systems and Applications Group provides decision support services to help industry and government reach sound policy and planning decisions. They identify critical factors that affect the development and commercialization of energy systems. The multidisciplinary IGT team provides economic and financial analyses, technology assessments, feasibility studies, market evaluations, policy analyses, and impact assessments. Their information can be used to plan for diversification, operations, research and development, investment, options identification, and market strategies. The authors cite sample analyses and summarize experience in such areas as pipeline cost estimation. 3 figures, 2 tables.

  19. Prospective bonding applications

    NASA Astrophysics Data System (ADS)

    Ancenay, H.; Benazet, D.

    1981-07-01

    Adhesive bonding in industry and in the laboratory is surveyed and prospects for its wider utilization are assessed. The economic impact of bonding technology on industry is discussed. Research is reviewed, centering on the development of nondestructive testing and inspection techniques. Traditional (wood) as well as new materials susceptible to bonding are considered. Applications in construction and civil engineering, in aeronautics, and in the automobile industry are covered. The use of glues in mechanical constructions, in assembling cylindrical parts, and in metal-metal bonding are examined. Hybrid assembling and bonding of composite materials are included.

  20. Widening ERTS applications

    NASA Technical Reports Server (NTRS)

    Mercanti, E. P.

    1974-01-01

    In less than two years of operation ERTS-1 is shown to have successfully completed its experimental mission and to be delivering an ever-increasing roster of benefits. The widening ERTS applications reviewed include air quality and weather modification, aid to oil exploration, ore-deposit exploration, short-lived event observation, flood area assessment and flood-plain mapping, land and water quality assessment, soil association mapping, crop production measurements, wildlife resources, drought and desertification studies, ground-water exploration, watershed surveys, snow and ice monitoring, surface water mapping, and iceberg surveys. Future projects and developments are also briefly reviewed.

  1. Space applications instrumentation systems

    NASA Technical Reports Server (NTRS)

    Minzner, R. A.; Oberholtzer, J. D.

    1972-01-01

    A compendium of resumes of 158 instrument systems or experiments, of particular interest to space applications, is presented. Each resume exists in a standardized format, permitting entries for 26 administrative items and 39 scientific or engineering items. The resumes are organized into forty groups determined by the forty spacecraft with which the instruments are associated. The resumes are followed by six different cross indexes, each organized alphabetically according to one of the following catagories: instrument name, acronym, name of principal investigator, name of organization employing the principal investigator, assigned experiment number, and spacecraft name. The resumes are associated with a computerized instrument resume search and retrieval system.

  2. AGU membership applications

    NASA Astrophysics Data System (ADS)

    Applications for membership have been received from the following individuals. The letter after the name denotes the proposed primary section affiliation.Henry D. I. Abarbanel (O), Julia C. Allen (H), Gwendolyn L. Anson (GP), Andrew Bakun (O), C. A. Bengtson (T), Patricia A. Berge (S), Peter R. Betzer (O), Pierre Boivin (V), Michael V. Capobianco (P), Martin C. Chapman (S), Chu-Yung Chen (V), Timothy J. Clarke (S), Steven C. Constable (GP), Michele Dermer (H), G. M. Dow (T), Carl E. Draper (G), Dean A. Dunn (O), I. B. Everingham (S).

  3. Laser applications in phlebology

    NASA Astrophysics Data System (ADS)

    Longo, Leonardo; Mancini, S.; Postiglione, Marco; Postiglione, M. G.

    2001-06-01

    PURPOSE: review of laser used in phlebology METHOD: critical analysis of scientific data taken from the literature and based on 25 years personal experience. RESULTS: we have three groups of laser applications in phlebology: for the diagnosis, as physical therapy and as surgical therapy. DISCUSSION AND CONCLUSION: the laser-doppler studies the microcirculations, the no-surgical therapy shown positive results in the treatment of venous ulcers and for the wound healing. It could be indicate also as antiphlogistic and anti-edema therapy, in superficial thrombophlebitis. The surgical laser is useful for the surgical cleaning of ulcers, for haemorroids, angiomas and telangiectases.

  4. International Space Station Environmental Control and Life Support System Acceptance Testing for the Pressurized Mating Adapters

    NASA Technical Reports Server (NTRS)

    Williams, David E.

    2008-01-01

    The International Space Station (ISS) Pressurized Mating Adapters (PMAs) Environmental Control and Life Support (ECLS) System is comprised of three subsystems: Atmosphere Control and Supply (ACS), Temperature and Humidity Control (THC), and Water Recovery and Management (WRM). PMAs 1 and 2 flew to ISS on Flight 2A and Pressurized Mating Adapter (PMA) 3 flew to ISS on Flight 3A. This paper provides a summary of the PMAs ECLS design and a detailed discussion of the ISS ECLS Acceptance Testing methodologies utilized for the PMAs.

  5. Direct application of geothermal energy

    SciTech Connect

    Reistad, G.M.

    1980-01-01

    An overall treatment of direct geothermal applications is presented with an emphasis on the above-ground engineering. The types of geothermal resources and their general extent in the US are described. The potential market that may be served with geothermal energy is considered briefly. The evaluation considerations, special design aspects, and application approaches for geothermal energy use in each of the applications are considered. The present applications in the US are summarized and a bibliography of recent studies and applications is provided. (MHR)

  6. Aerospace materials for nonaerospace applications

    NASA Technical Reports Server (NTRS)

    Johnston, R. L.; Dawn, F. S.

    1974-01-01

    Many of the flame-resistant nonmetallic materials that were developed for the Apollo and Skylab programs are discussed for commercial and military applications. Interchanges of information are taking place with the government agencies, industries, and educational institutions, which are interested in applications of fire-safe nonmetallic materials. These materials are particularly applicable to the design of aircraft, mass transit interiors, residential and public building constructions, nursing homes and hospitals, and to other fields of fire safety applications. Figures 22, 23 and 24 show the potential nonaerospace applications of flame-resistant aerospace materials are shown.

  7. Novel oral laser applications

    NASA Astrophysics Data System (ADS)

    Yousif, A.; Strassl, M.; Beer, F.; Verhagen, L.; Wittschier, M.; Wintner, E.

    2007-03-01

    In dental hard tissue ablation, ultra-short laser pulses have proven sufficiently their potential for material ablation with negligible collateral damage providing many advantages. The absence of micro-cracks and the possibility to avoid overheating of the pulp during dental cavity preparation may be among the most important issues, the latter opening up an avenue for potential painless treatment. Beside the evident short interaction time of laser radiation with the irradiated tissue, scanning of the ultra-short pulse trains turned out to be crucial for ablating cavities of required quality and shape. Additionally, long-pulsed laser systems have demonstrated successfully their suitability for decontamination purposes. In this paper, an overview of different indications for laser application in dental therapies in both pulse regimes is presented. A special focus is set on the decontamination of dental implants in periimplantitis therapy. Having employed commercially available long pulse systems for dental applications and ultra-short 330 fs pulses, we present first results for temperature development and corresponding ablation thresholds for dental implants, as in the future more gentle implant cleaning by ultra-short laser pulses could become of interest.

  8. Nanosilicon for Photonic Applications

    NASA Astrophysics Data System (ADS)

    Ghoshal, S. K.; Mohan, Devendra; Kassa, Tadesse Tenaw; Sharma, Sunita

    This presentation is a short review of some scientific insights on the possibilities of photonic applications of nanostructured silicon (NS-Si), porous Si (p-Si) and Si nanocrystals (NC-Si), one of the most interesting problems in nano-crystallite physics. The emission mechanism of a very bright photo-luminescence (PL) band and relatively weak electro-luminescence (EL) are presently the main issue. The basic question lies in whether the emission is an extrinsic or intrinsic property of nanocrystals. It is important from a fundamental physics viewpoint because of the potential application of Si wires and quantum dots in optoelectronic devices and information technology. Nanostructuring silicon is an effective way to turn silicon into a photonic material. It is observed that low-dimensional (one and two dimensions) silicon shows light amplification, photon confinement, photon trapping as well as non-linear optical effects. There is strong evidence of light localization and gas sensing properties of such nanostructures. Future nano-technology would replace electrical with optical interconnects, which has appealing potential for higher-speed performance and immunity to signal cross talk.

  9. Applications of Groundwater Helium

    USGS Publications Warehouse

    Kulongoski, Justin T.; Hilton, David R.

    2011-01-01

    Helium abundance and isotope variations have widespread application in groundwater-related studies. This stems from the inert nature of this noble gas and the fact that its two isotopes ? helium-3 and helium-4 ? have distinct origins and vary widely in different terrestrial reservoirs. These attributes allow He concentrations and 3He/4He isotope ratios to be used to recognize and quantify the influence of a number of potential contributors to the total He budget of a groundwater sample. These are atmospheric components, such as air-equilibrated and air-entrained He, as well as terrigenic components, including in situ (aquifer) He, deep crustal and/or mantle He and tritiogenic 3He. Each of these components can be exploited to reveal information on a number of topics, from groundwater chronology, through degassing of the Earth?s crust to the role of faults in the transfer of mantle-derived volatiles to the surface. In this review, we present a guide to how groundwater He is collected from aquifer systems and quantitatively measured in the laboratory. We then illustrate the approach of resolving the measured He characteristics into its component structures using assumptions of endmember compositions. This is followed by a discussion of the application of groundwater He to the types of topics mentioned above using case studies from aquifers in California and Australia. Finally, we present possible future research directions involving dissolved He in groundwater.

  10. Nanocontrollers for biomedical applications.

    PubMed

    Frenger, P

    1996-01-01

    Several semiconductor companies now manufacture low cost single-chip microcontrollers in dual inline packages having twenty or fewer pins. The controllers are field programmable by means of inexpensive development boards linked to personal computers. These processors were designed with a minimalist philosophy which provide them with only a few dozen bytes of on-chip RAM, hundreds of bytes of PROM, a parallel port, a counter/timer, and reduced instruction sets. The better-equipped members of this class may have special on-chip hardware, such as analog-to-digital input, pulse-width modulation output and a serial port. Most must be programmed in assembler, although some support BASIC, "C" or other languages. Their tiny size, design simplicity and operational single-mindedness earn them the nickname "nanocontrollers". Despite meager resources, these controllers can be successfully employed in a variety of biomedical applications. Such uses include: consolidation of multi-chip "glue logic" circuitry; functioning as subsystem elements in complex designs; serving as device drivers or protocol converters; and forming the building blocks of hypercube processor arrays or artificial neural networks. This paper describes the general capabilities, special features, and some application examples of "nanocontroller" technology. PMID:8672686

  11. ): laser processing and applications

    NASA Astrophysics Data System (ADS)

    Fricke-Begemann, T.; Meinertz, J.; Weichenhain-Schriever, R.; Ihlemann, J.

    2014-10-01

    Substoichiometric silicon oxide SiOx with x < 2 in form of evaporated or sputtered thin films offers a versatile material basis for laser ablation techniques such as film patterning, laser-induced forward transfer, or laser-induced backside dry etching. Applications in the field of (micro-) optics are favoured strongly by the fact that SiOx can be oxidised to UV-transparent SiO2 by thermal treatment (furnace or laser annealing). On the other hand, with x ≈ 1, SiOx exhibits an absorption coefficient of >105 cm-1 in the deep UV below 250 nm, comparable to strongly absorbing polymers such as polyimide. This enables precise ablation with, e.g., excimer lasers at moderate fluences. For example, UV-transparent diffractive elements or phase masks are made by laser patterning of an appropriate SiOx film and subsequent oxidation to SiO2. Modifications of the basic film ablation process lead to novel surface topographies such as blister or cup arrays with potential non-optical applications, e.g., in micro-/nanofluidics.

  12. Surety applications in transportation

    SciTech Connect

    Matalucci, R.V.; Miyoshi, D.S.

    1998-01-01

    Infrastructure surety can make a valuable contribution to the transportation engineering industry. The lessons learned at Sandia National Laboratories in developing surety principles and technologies for the nuclear weapons complex and the nuclear power industry hold direct applications to the safety, security, and reliability of the critical infrastructure. This presentation introduces the concepts of infrastructure surety, including identification of the normal, abnormal, and malevolent threats to the transportation infrastructure. National problems are identified and examples of failures and successes in response to environmental loads and other structural and systemic vulnerabilities are presented. The infrastructure surety principles developed at Sandia National Laboratories are described. Currently available technologies including (a) three-dimensional computer-assisted drawing packages interactively combined with virtual reality systems, (b) the complex calculational and computational modeling and code-coupling capabilities associated with the new generation of supercomputers, and (c) risk-management methodologies with application to solving the national problems associated with threats to the critical transportation infrastructure are discussed.

  13. Intermetallics for structural applications

    SciTech Connect

    Sikka, V.K.; Deevi, S.C.

    1995-09-01

    Intermetallics are introduced as possible structural materials. The attributes and useful temperature limits of eight of the most likely candidates have been described. In addition, detailed descriptions are given for chemical compositions, corrosion properties, mechanical properties, melting and processing, and applications of Ni{sub 3}Al and Fe{sub 3}Al-based alloys. Mechanical properties of Ni{sub 3}Al-based alloys are compared with commercially used HU alloys in the cast condition and Haynes 214 in the wrought condition. The mechanical properties of Fe{sub 3}Al-based alloys are compared with an oxide-dispersion-strengthened (ODS) Inco alloy MA-956. Comparisons have shown that Ni{sub 3}Al-based alloys offer the best combination of oxidation and carburization resistance and are significantly stronger than the commercially used HU alloy for many of the furnace-fixture applications. However, the Fe{sub 3}Al-based alloys, which offer the best sulfidation resistance of the commercially available alloys, are significantly weaker in creep than the ODS MA-956 alloy. Even with the current strength level, Fe{sub 3}Al-based alloys are superior as porous, sintered metal filters for hot-gas cleanup in coal gasification systems. Oxide-dispersion strengthening of the Fe{sub 3}Al-based alloys is currently under way to improve their creep strength.

  14. Medicinal applications of fullerenes

    PubMed Central

    Bakry, Rania; Vallant, Rainer M; Najam-ul-Haq, Muhammad; Rainer, Matthias; Szabo, Zoltan; Huck, Christian W; Bonn, Günther K

    2007-01-01

    Fullerenes have attracted considerable attention in different fields of science since their discovery in 1985. Investigations of physical, chemical and biological properties of fullerenes have yielded promising information. It is inferred that size, hydrophobicity, three-dimensionality and electronic configurations make them an appealing subject in medicinal chemistry. Their unique carbon cage structure coupled with immense scope for derivatization make them a potential therapeutic agent. The study of biological applications has attracted increasing attention despite the low solubility of carbon spheres in physiological media. The fullerene family, and especially C60, has appealing photo, electrochemical and physical properties, which can be exploited in various medical fields. Fullerene is able to fit inside the hydrophobic cavity of HIV proteases, inhibiting the access of substrates to the catalytic site of enzyme. It can be used as radical scavenger and antioxidant. At the same time, if exposed to light, fullerene can produce singlet oxygen in high quantum yields. This action, together with direct electron transfer from excited state of fullerene and DNA bases, can be used to cleave DNA. In addition, fullerenes have been used as a carrier for gene and drug delivery systems. Also they are used for serum protein profiling as MELDI material for biomarker discovery. In this review we report the aspects of medicinal applications of fullerenes. PMID:18203430

  15. Haloalkane dehalogenases: biotechnological applications.

    PubMed

    Koudelakova, Tana; Bidmanova, Sarka; Dvorak, Pavel; Pavelka, Antonin; Chaloupkova, Radka; Prokop, Zbynek; Damborsky, Jiri

    2013-01-01

    Haloalkane dehalogenases (EC 3.8.1.5, HLDs) are α/β-hydrolases which act to cleave carbon-halogen bonds. Due to their unique catalytic mechanism, broad substrate specificity and high robustness, the members of this enzyme family have been employed in several practical applications: (i) biocatalytic preparation of optically pure building-blocks for organic synthesis; (ii) recycling of by-products from chemical processes; (iii) bioremediation of toxic environmental pollutants; (iv) decontamination of warfare agents; (v) biosensing of environmental pollutants; and (vi) protein tagging for cell imaging and protein analysis. This review discusses the application of HLDs in the context of the biochemical properties of individual enzymes. Further extension of HLD uses within the field of biotechnology will require currently limiting factors - such as low expression, product inhibition, insufficient enzyme selectivity, low affinity and catalytic efficiency towards selected substrates, and instability in the presence of organic co-solvents - to be overcome. We propose that strategies based on protein engineering and isolation of novel HLDs from extremophilic microorganisms may offer solutions. PMID:22965918

  16. Corrosion in bioprocessing applications.

    PubMed

    Junker, Beth

    2009-01-01

    Corrosion in bioprocessing applications is described for a 25-year-old bioprocessing pilot plant facility. Various available stainless steel alloys differ greatly in properties owing to the impact of specific alloying elements and their concentrations. The alloy property evaluated was corrosion resistance as a function of composition under typical bioprocessing conditions such as sterilization, fermentation, and cleaning. Several non-uniform forms of corrosion relevant to bioprocessing applications (e.g., pitting, crevice corrosion, intergranular attack) were investigated for their typical causes and effects, as well as alloy susceptibility. Next, the corrosion resistance of various alloys to specific bioprocessing-relevant sources of corrosion (e.g., medium components, acids/bases used for pH adjustment, organic acid by-products) was evaluated, along with the impact of temperature on corrosion progression. Best practices to minimize corrosion included considerations for fabrication (e.g., welding, heat treatments) and operational (e.g., sterilization, media component selection, cleaning) approaches. Assessments and repair strategies for observed corrosion events were developed and implemented, resulting in improved vessel and overall facility longevity. PMID:18512080

  17. Cardiac Applications of Optogenetics

    PubMed Central

    Ambrosi, Christina M.; Klimas, Aleksandra; Yu, Jinzhu; Entcheva, Emilia

    2014-01-01

    In complex multicellular systems, such as the brain or the heart, the ability to selectively perturb and observe the response of individual components at the cellular level and with millisecond resolution in time, is essential for mechanistic understanding of function. Optogenetics uses genetic encoding of light sensitivity (by the expression of microbial opsins) to provide such capabilities for manipulation, recording, and control by light with cell specificity and high spatiotemporal resolution. As an optical approach, it is inherently scalable for remote and parallel interrogation of biological function at the tissue level; with implantable miniaturized devices, the technique is uniquely suitable for in vivo tracking of function, as illustrated by numerous applications in the brain. Its expansion into the cardiac area has been slow. Here, using examples from published research and original data, we focus on optogenetics applications to cardiac electrophysiology, specifically dealing with the ability to manipulate membrane voltage by light with implications for cardiac pacing, cardioversion, cell communication, and arrhythmia research, in general. We discuss gene and cell delivery methods of inscribing light sensitivity in cardiac tissue, functionality of the light-sensitive ion channels within different types of cardiac cells, utility in probing electrical coupling between different cell types, approaches and design solutions to all-optical electrophysiology by the combination of optogenetic sensors and actuators, and specific challenges in moving towards in vivo cardiac optogenetics. PMID:25035999

  18. Environmental Applications of Nanotechnology

    NASA Astrophysics Data System (ADS)

    Keller, Arturo A.

    2014-07-01

    Engineered nanomaterials (ENMs) are currently used in many applications including agriculture (Gruère, 2012; Khot et al. 2012; Lopez-Moreno et al. 2010; Peralta-Videa et al. 2011; Zhao et al. 2012), aerogels (Bigall et al. 2009), aerospace (Baur and Silverman, 2007), automotive (Coelho et al. 2012; Presting and König, 2003; Salonitis et al. 2010), catalysts (Zhou et al. 2011), coatings, paints and pigments (Dhoke et al. 2009; Gopalakrishnan et al. 2011; Khanna, 2008), composites (Borchardt, 2003; Khanna and Bakshi, 2009; Petrov and Georgiev, 2012; Sahoo et al. 2010), construction (Lee et al. 2010), cosmetics (Musee, 2011; Sabitha et al. 2012; Singh and Nanda, 2012), electronics and optics (Alda et al. 2005; Avasthi et al. 2007; Song et al. 2012; Subramanian and Takhee, 2012), energy (Serrano et al. 2009), environmental remediation (Dionysiou 2004; Khin et al. 2012), filtration and purification (Dhakras, 2011; Savage and Diallo, 2005), food products (Blasco and Picó, 2011; Weiss et al. 2006), medical (Boisseau and Loubaton, 2011; Farokhzad and Langer, 2006), packaging (Silvestre et al. 2011), paper and board (Kharisov and Kharissova, 2010), plastics, security (Marín and Merkoçi, 2012), sensors (Ding et al. 2010; Duncan et al. 2012; Su et al. 2012; Tan et al. 2012), and textiles (Qian and Hinestroza, 2004; Wong et al. 2006), and research is underway on many new applications...

  19. Microneedles and their applications.

    PubMed

    Sachdeva, Vishal; Banga, Ajay K

    2011-05-01

    Microneedle mediated microporation has proved its potential to enhance the delivery of therapeutic drug molecules through skin over the last one decade. Several patents have been granted and cutting edge research is going on particularly for the delivery of biopharmaceuticals (macromolecules like protein or peptides). The technology involves use of micron sized needles made of diverse materials to form microchannels into the stratum corneum (or deeper), outermost barrier layer of the skin. These microchannels are deep enough to facilitate efficient drug delivery through disrupted stratum corneum but short enough to avoid bleeding or pain. So far, the microneedle technology has been explored for drug and vaccine delivery through transcutaneous route. However, the miniaturized nature of these microneedles and anticipated minimal invasiveness has led the scientists to explore and patent its possible use for several other applications.The use of this technology in combination with other enhancement techniques has also gained recent attention. This review article focuses on the latest developments in the field of microneedles as described in patent and research literature. Comprehensive review of several topics including device design/fabrication, formulation development, safety/regulatory issues, therapeutic applications and major challenges in the commercialization of microneedles as medical devices has been presented here. PMID:21453248

  20. Fuel cell applications literature review

    NASA Astrophysics Data System (ADS)

    Nochumson, D. H.; Altseimer, J. H.; Williamson, K. D., Jr.; Frank, J. A.; Peaslee, A. T.; Martinez, A. J.; Stroup, C. A.

    1985-03-01

    The fuel cell applications literature is reviewed and evaluated. The purpose is to identify those applications that show promise. Over 40 computerized data bases were queried, and over 4000 abstracts were screened, resulting in the selection of over 600 pertinent documents that were entered into a fuel cell applications computerized data base. These documents were reviewed and evaluated. Fuel cells will need to be manufactured at low cost in order to compete against internal combustion engines for land transportation applications. Further study is recommended to evaluate fuel cell use in both fixed applications (industrial, institutional, and military) and mobile applications (marine, aircraft, space, and military land transportation). In addition to the recommendations of this report, a computerized data base of literature covering fuel cell uses and applications has been established and is available for use.