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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. 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),...

  8. 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

  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. 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...

  16. 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

  17. 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.

  18. 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.

  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. 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.''...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  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 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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....

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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. ]...

  16. 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,...

  17. 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,...

  18. 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...

  19. 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...

  20. 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...

  1. 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 §...

  2. 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 §...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  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 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 §...

  17. 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 §...

  18. 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 §...

  19. 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 §...

  20. 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 §...

  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 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  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. 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,...

  17. 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...

  18. 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...

  19. 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

  20. 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...

  1. 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...

  2. 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

  3. 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

  4. [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

  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. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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....

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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,...

  4. 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...

  5. 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...

  6. 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,...

  7. 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...

  8. 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,......

  9. 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,......

  10. 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,......