75 FR 59746 - Criminal Division; Agency Information Collection Activities: Proposed Collection; Comments Requested

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... Review: Request for Registration Under the Gambling Devices Act of 1962. The Department of Justice (DOJ..., Gambling Device Registration Program, JCK Building, Room 1040, Washington, DC 20530-0001. Written comments... the Gambling Devices Act of 1962. (3) Agency form number, if any, and the applicable component of the...

42 CFR 403.902 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., repackagers, relabelers, and kit assemblers) that do not hold title to any covered drug, device, biological or... sister corporations. Covered device means any device for which payment is available under Title XVIII of the Act or under a State plan under Title XIX or XXI of the Act (or a waiver of such plan), either...

42 CFR 403.902 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., repackagers, relabelers, and kit assemblers) that do not hold title to any covered drug, device, biological or... sister corporations. Covered device means any device for which payment is available under Title XVIII of the Act or under a State plan under Title XIX or XXI of the Act (or a waiver of such plan), either...

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

... Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the... could lead to potentially debilitating or fatal thromboembolism. b. Excessive hemolysis--poor design of the hemodynamic characteristics of the device can lead to excess hemolysis. c. Inability to support...

28 CFR 3.1 - Definition.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Definition. 3.1 Section 3.1 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.1 Definition. For the purpose of this part, the term Act means the Act of January 2, 1951, 64 Stat. 1134, as amended by the Gambling Devices Act of 1962...

28 CFR 3.1 - Definition.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Definition. 3.1 Section 3.1 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.1 Definition. For the purpose of this part, the term Act means the Act of January 2, 1951, 64 Stat. 1134, as amended by the Gambling Devices Act of 1962...

28 CFR 3.1 - Definition.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Definition. 3.1 Section 3.1 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.1 Definition. For the purpose of this part, the term Act means the Act of January 2, 1951, 64 Stat. 1134, as amended by the Gambling Devices Act of 1962...

28 CFR 3.1 - Definition.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Definition. 3.1 Section 3.1 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.1 Definition. For the purpose of this part, the term Act means the Act of January 2, 1951, 64 Stat. 1134, as amended by the Gambling Devices Act of 1962...

28 CFR 3.1 - Definition.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Definition. 3.1 Section 3.1 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.1 Definition. For the purpose of this part, the term Act means the Act of January 2, 1951, 64 Stat. 1134, as amended by the Gambling Devices Act of 1962...

Regulatory aspects of noninvasive glucose measurements.

PubMed

Gutman, Steve; Bernhardt, Patricia; Pinkos, Arleen; Moxey-Mims, Marva; Knott, Thomas; Cooper, Jean

2002-01-01

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the Act) established three regulatory classes for medical devices. Section 513 of the Act specifies three classes based upon the degree of control and Food and Drug Administration (FDA) oversight that is necessary to assure that the various types of devices are safe and effective. High-risk devices are placed into the most regulated device class, Class III. Under Section 515 of the Act, all devices placed in Class III are subject to premarket approval (PMA) requirements. PMA by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Advisory panel review is required of virtually all original submissions. Manufacturing facilities of devices requiring PMA approval are also subject to preapproval inspection to assure data integrity and compliance with good manufacturing practices. An approved PMA is granted for marketing a particular medical device for a particular intended use. FDA considers noninvasive and minimally invasive glucose devices that are intended to measure, monitor, or predict blood glucose levels in diabetics to be high-risk medical devices. These devices will have a significant potential impact on the medical care of people with diabetes. The technology offers potential improvements in the quality of life, enhanced blood glucose control through increased frequency of testing, or access to testing, in a broader range of patients. However, the technology is not yet well understood, and the information obtained from these devices is often different from the information that has been the traditional base for the management of diabetes. As a result, FDA requires both analytical and clinical studies to support the intended claims for these new devices.

Medical devices; reclassification of the topical oxygen chamber for extremities. Final rule.

PubMed

2011-04-25

The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of Health and Human Services's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Medical Device Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities,'' which will serve as the special control for this device.

Orthopedic devices; classification for the resorbable calcium salt bone void filler device. Final rule.

PubMed

2003-06-02

The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.

21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

78 FR 2998 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-15

... on FDA's Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards..., and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize... accessible at the Agency's Internet site. See section VI of this document for electronic access information...

Method and apparatus for suppressing waves in a borehole

DOEpatents

West, Phillip B.

2005-10-04

Methods and apparatus for suppression of wave energy within a fluid-filled borehole using a low pressure acoustic barrier. In one embodiment, a flexible diaphragm type device is configured as an open bottomed tubular structure for disposition in a borehole to be filled with a gas to create a barrier to wave energy, including tube waves. In another embodiment, an expandable umbrella type device is used to define a chamber in which a gas is disposed. In yet another embodiment, a reverse acting bladder type device is suspended in the borehole. Due to its reverse acting properties, the bladder expands when internal pressure is reduced, and the reverse acting bladder device extends across the borehole to provide a low pressure wave energy barrier.

21 CFR 821.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... patient. Effective tracking of devices from the manufacturing facility, through the distributor network..., and licensed practitioners) and, ultimately, to the patient is necessary for the effectiveness of remedies prescribed by the act, such as patient notification (section 518(a) of the act) or device recall...

21 CFR 821.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... patient. Effective tracking of devices from the manufacturing facility, through the distributor network..., and licensed practitioners) and, ultimately, to the patient is necessary for the effectiveness of remedies prescribed by the act, such as patient notification (section 518(a) of the act) or device recall...

21 CFR 821.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... patient. Effective tracking of devices from the manufacturing facility, through the distributor network..., and licensed practitioners) and, ultimately, to the patient is necessary for the effectiveness of remedies prescribed by the act, such as patient notification (section 518(a) of the act) or device recall...

The FDA role in contact lens development and safety.

PubMed

Lippman, R E

1990-01-01

The Food and Drug Administration (FDA) exercises a multifaceted role in fulfilling its mission of enforcing the Federal Food, Drug and Cosmetic Act (Act), functioning not only as industry regulator and consumer protector, but also as scientific advisor and consumer educator regarding medical devices, drugs, foods, cosmetics, and veterinary medicine. Medical devices are regulated within the Center for Devices and Radiological Health. Contact lenses are regulated under the authority of the medical device amendments. The Center is responsible for promulgating regulations, publishing guidelines, and developing written guidance in enforcing the Act, and also for guiding manufacturers of medical devices in safe and effective product development. Other components deal with the compliance of manufacturers with the marketing of medical devices within the meaning of the Act, and through labeling requirements of the Act and consumer education and informational activities. As for contact lenses, the process of updating product development regulations and guidelines is an ongoing activity. The most recent version of the Contact Lens Guideline Document, issued in April 1988, contains two major revisions involving preclinical and clinical testing. The first redefines plastics into one materials category, thus reducing testing requirements with respect to animal toxicology studies and other preclinical areas. The second revision restricts clinical testing requirements to allow confirmatory trials in applications for new daily wear lenses. The intention was to maintain the ability of studies to detect major material or design flaws in lenses, thus boosting confidence in their performance while eliminating unnecessary trials.(ABSTRACT TRUNCATED AT 250 WORDS)

16 CFR § 1507.9 - Toy smoke devices and flitter devices.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Toy smoke devices and flitter devices. Â... SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.9 Toy smoke devices and flitter devices. (a) Toy smoke... fuse and firstfire upon ignition) during normal operation. (b) Toy smoke devices and flitter devices...

16 CFR 1507.9 - Toy smoke devices and flitter devices.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Toy smoke devices and flitter devices. 1507... SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.9 Toy smoke devices and flitter devices. (a) Toy smoke... fuse and firstfire upon ignition) during normal operation. (b) Toy smoke devices and flitter devices...

16 CFR 1507.9 - Toy smoke devices and flitter devices.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Toy smoke devices and flitter devices. 1507... SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.9 Toy smoke devices and flitter devices. (a) Toy smoke... fuse and firstfire upon ignition) during normal operation. (b) Toy smoke devices and flitter devices...

16 CFR 1507.9 - Toy smoke devices and flitter devices.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Toy smoke devices and flitter devices. 1507... SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.9 Toy smoke devices and flitter devices. (a) Toy smoke... fuse and firstfire upon ignition) during normal operation. (b) Toy smoke devices and flitter devices...

21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

Hematology and pathology devices; reclassification of the automated differential cell counter. Final rule.

PubMed

2002-01-14

The Food and Drug Administration (FDA) is reclassifying the automated differential cell counter (ADCC) from class III (premarket approval) into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA" as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is being undertaken based on new information submitted in a reclassification petition from the International Society for Laboratory Hematology (ISLH), under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997.

16 CFR 1507.9 - Toy smoke devices and flitter devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.9 Toy smoke devices and flitter devices. (a) Toy smoke... shall not be of such color and configuration so as to be confused with banned fireworks such as M-80...

Tank Level Detection Devices for the Carriage of Oil : Oil Pollution Act of 1990, Section 4110

DOT National Transportation Integrated Search

1992-12-29

This study was conducted to assess the technical feasibility of satisfying the requirements of Section 4110 of the Oil Pollution Act of 1990 (OPA 90), which calls for minimum regulatory standards tank level monitoring devices in teh cargo tanks of ta...

17 CFR 240.0-10 - Small entities under the Securities Exchange Act for purposes of the Regulatory Flexibility Act.

Code of Federal Regulations, 2011 CFR

2011-04-01

... interrogation devices or moving tickers at all times during the preceding fiscal year (or in the time that it... purposes of paragraph (g) of this section, “interrogation device” shall refer to any device that may be...

17 CFR 240.0-10 - Small entities under the Securities Exchange Act for purposes of the Regulatory Flexibility Act.

Code of Federal Regulations, 2010 CFR

2010-04-01

... interrogation devices or moving tickers at all times during the preceding fiscal year (or in the time that it... purposes of paragraph (g) of this section, “interrogation device” shall refer to any device that may be...

17 CFR 240.0-10 - Small entities under the Securities Exchange Act for purposes of the Regulatory Flexibility Act.

Code of Federal Regulations, 2012 CFR

2012-04-01

... interrogation devices or moving tickers at all times during the preceding fiscal year (or in the time that it... purposes of paragraph (g) of this section, “interrogation device” shall refer to any device that may be...

17 CFR 240.0-10 - Small entities under the Securities Exchange Act for purposes of the Regulatory Flexibility Act.

Code of Federal Regulations, 2014 CFR

2014-04-01

... interrogation devices or moving tickers at all times during the preceding fiscal year (or in the time that it... purposes of paragraph (g) of this section, “interrogation device” shall refer to any device that may be...

17 CFR 240.0-10 - Small entities under the Securities Exchange Act for purposes of the Regulatory Flexibility Act.

Code of Federal Regulations, 2013 CFR

2013-04-01

... interrogation devices or moving tickers at all times during the preceding fiscal year (or in the time that it... purposes of paragraph (g) of this section, “interrogation device” shall refer to any device that may be...

33 CFR 159.16 - Authorization to label devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

....S. Coast Guard pursuant to section 312 of the Federal Water Pollution Control Act Amendments of 1972... required by section 312(h)(4) of the Federal Water Pollution Control Act Amendments of 1972, which makes it... (CONTINUED) POLLUTION MARINE SANITATION DEVICES Certification Procedures § 159.16 Authorization to label...

Pattern Recognition by Retina-Like Devices.

ERIC Educational Resources Information Center

Weiman, Carl F. R.; Rothstein, Jerome

This study has investigated some pattern recognition capabilities of devices consisting of arrays of cooperating elements acting in parallel. The problem of recognizing straight lines in general position on the quadratic lattice has been completely solved by applying parallel acting algorithms to a special code for lines on the lattice. The…

[Medical Devices Law for pain therapists].

PubMed

Regner, M; Sabatowski, R

2016-08-01

Medical Devices Law is a relatively new legal system, which has replaced the Medical Devices Regulations still well-known in Germany. German Medical Devices Law is based on European directives, which are, in turn, incorporated into national law by the Medical Devices Act. The Medical Devices Act is a framework law and covers a number of regulations that address specific topics within Medical Devices Law. In turn, in individual regulations, reference is made to guidelines, recommendations, etc. from other sources that provide detailed technical information on specific topics. Medical Devices Law is a very complex legal system, which needs to be permanently observed due to constant updating and adjustment. In the current article, the design and the structure of the system will be described, but special emphasis will be laid on important problem areas that need to be considered when applying and operating medical products, in this case by pain therapists in particular.

16 CFR 1507.8 - Wheel devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Wheel devices. 1507.8 Section 1507.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.8 Wheel devices. Drivers in fireworks devices commonly known as “wheels” shall be...

75 FR 14510 - Implementation of Device Registration and Listing Requirements Enacted in the Public Health...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 807 [Docket No... in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration...

75 FR 53702 - Medical Device User Fee Act; Public Meeting; Request for Comments; Amendment of Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2010-N-0389] Medical Device User Fee Act; Public Meeting; Request for Comments; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

[Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products].

PubMed

Sato, Yoji

2014-01-01

In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the revisions to the Pharmaceutical Affairs Act, which was also renamed as the Therapeutic Products Act (TPA). One of the aims of the new/revised Acts is to promote the development and translation of and access to regenerative/cellular therapies. In the TPA, a product derived from processing cells is categorized as a subgroup of "regenerative medicine, cellular therapy and gene therapy products" (RCGPs), products distinct from pharmaceuticals and medical devices, allowing RCGPs to obtain a conditional and time- limited marketing authorization much earlier than that under the conventional system. To foster not only RCGPs, but also innovative pharmaceuticals and medical devices, the Ministry of Health, Labour and Welfare recently launched Translational Research Program for Innovative Pharmaceuticals, Medical Devices and RCGPs. This mini-review introduces contributions of the National Institute of Health Sciences (NIHS) to research projects on RCGPs in the Program.

21 CFR 886.4270 - Intraocular gas.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4270 Intraocular gas. (a) Identification. An intraocular gas is a device consisting of a gaseous fluid intended to be introduced into the eye to place pressure... required. As of May 28, 1976, an approval under section 515 of the act is required before this device may...

21 CFR 806.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... this part: (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) Agency or FDA means the Food and... device that has not been marketed or that has not left the direct control of the manufacturer, i.e., the device is located on the premises owned, or under the control of, the manufacturer, and no portion of the...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

Fast-acting self-healing metallic fuse.

NASA Technical Reports Server (NTRS)

Schwartz, F. C.; Renton, C. A.; Rabinovici, B.

1971-01-01

Description of a fast-acting nonmechanical self-healing mercury fuse capable of protecting a high current circuit or device from overcurrent fault damages. Basically the self-healing fuse consists of two enclosed mercury reservoirs connected by a fine capillary tube filled with mercury that serves as the fusing element. It is pointed out that a better understanding of the energy conversion process involved in the operation of the device could help explore other device configurations (such as a tapering geometry and use of magnetic field to drive the arc into the fuse wall on inductive loads, etc.) and thus extend the range of capabilities for this type of protective device.

Medical Device Innovation in the Era of the Affordable Care Act: The End of Sexy.

PubMed

Mattke, Soeren; Liu, Hangsheng; Orr, Patrick

2016-06-20

In this article, the authors explore why medical device innovation has traditionally been geared so thoroughly toward improving performance, with little regard to cost. They argue that the changing incentives in the health care sector and the move to value-based payment models, accelerated by the implementation of the Affordable Care Act, will force device manufacturers to redirect investments from the spectacular toward the prudent, which they dub "the end of sexy." The authors explore consequences for manufacturers, investors, and policymakers.

Medical Device Innovation in the Era of the Affordable Care Act

PubMed Central

Mattke, Soeren; Liu, Hangsheng; Orr, Patrick

2016-01-01

Abstract In this article, the authors explore why medical device innovation has traditionally been geared so thoroughly toward improving performance, with little regard to cost. They argue that the changing incentives in the health care sector and the move to value-based payment models, accelerated by the implementation of the Affordable Care Act, will force device manufacturers to redirect investments from the spectacular toward the prudent, which they dub “the end of sexy.” The authors explore consequences for manufacturers, investors, and policymakers. PMID:28083437

Acoustic charge transport technology investigation for advanced development transponder

NASA Technical Reports Server (NTRS)

Kayalar, S.

1993-01-01

Acoustic charge transport (ACT) technology has provided a basis for a new family of analog signal processors, including a programmable transversal filter (PTF). Through monolithic integration of ACT delay lines with GaAs metal semiconductor field effect transistor (MESFET) digital memory and controllers, these devices significantly extend the performance of PTF's. This article introduces the basic operation of these devices and summarizes their present and future specifications. The production and testing of these devices indicate that this new technology is a promising one for future space applications.

21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

Administration of the Radiation Control for Health and Safety Act of 1968, Public Law 90-602, (1987 annual report). Report for January-December 1987

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

This document is an annual report submitted to the President for transmittal to the Congress. The Food and Drug Administration, through its Center for Devices and Radiological Health, is responsible for the day-to-day administration of the Radiation Control for Health and Safety Act of 1968. The report provides a summary of the operations of the Center in carrying out that responsibility for calendar year 1987. In reviewing the operations of the CDRH as reported in the document, it should be kept in mind that the day-to-day administration of the Act is only part of the Center's function. Other responsibilities includemore » the administration and enforcement of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (not covered in the report). Manufacturers of electronic products are required by 21 CFR 1002.20 to report accidental radiation occurrences to the CDRH. The Center no longer maintains a Radiation Incidents Registry, since accidental radiation occurrences are reported through the Device Experience Network (DEN) and through the requirements of the Medical Device Reporting (MDR) regulations.« less

Medicare program; replacement of reasonable charge methodology by fee schedules for parenteral and enteral nutrients, equipment, and supplies. Final rule.

PubMed

2001-08-28

This final rule implements fee schedules for payment of parenteral and enteral nutrition (PEN) items and services furnished under the prosthetic device benefit, defined in section 1861(s)(8) of the Social Security Act. The authority for establishing these fee schedules is provided by the Balanced Budget Act of 1997, which amended the Social Security Act at section 1842(s). Section 1842(s) of the Social Security Act specifies that statewide or other area wide fee schedules may be implemented for the following items and services still subject to the reasonable charge payment methodology: medical supplies; home dialysis supplies and equipment; therapeutic shoes; parenteral and enteral nutrients, equipment, and supplies; electromyogram devices; salivation devices; blood products; and transfusion medicine. This final rule describes changes made to the proposed fee schedule payment methodology for these items and services and provides that the fee schedules for PEN items and services are effective for all covered items and services furnished on or after January 1, 2002. Fee schedules will not be implemented for electromyogram devices and salivation devices at this time since these items are not covered by Medicare. In addition, fee schedules will not be implemented for medical supplies, home dialysis supplies and equipment, therapeutic shoes, blood products, and transfusion medicine at this time since the data required to establish these fee schedules are inadequate.

Electric turbocompound control system

DOEpatents

Algrain, Marcelo C [Dunlap, IL

2007-02-13

Turbocompound systems can be used to affect engine operation using the energy in exhaust gas that is driving the available turbocharger. A first electrical device acts as a generator in response to turbocharger rotation. A second electrical device acts as a motor to put mechanical power into the engine, typically at the crankshaft. Apparatus, systems, steps, and methods are described to control the generator and motor operations to control the amount of power being recovered. This can control engine operation closer to desirable parameters for given engine-related operating conditions compared to actual. The electrical devices can also operate in "reverse," going between motor and generator functions. This permits the electrical device associated with the crankshaft to drive the electrical device associated with the turbocharger as a motor, overcoming deficient engine operating conditions such as associated with turbocharger lag.

26 CFR 601.522 - Power of attorney.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (Machine Guns, Destructive Devices, and Certain Other Firearms), Internal Revenue Code, title 1 of the Gun Control Act of 1968, or the Federal Alcohol Administration Act, which is filed with or acted on by (1) the...

26 CFR 601.522 - Power of attorney.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (Machine Guns, Destructive Devices, and Certain Other Firearms), Internal Revenue Code, title 1 of the Gun Control Act of 1968, or the Federal Alcohol Administration Act, which is filed with or acted on by (1) the...

26 CFR 601.522 - Power of attorney.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (Machine Guns, Destructive Devices, and Certain Other Firearms), Internal Revenue Code, title 1 of the Gun Control Act of 1968, or the Federal Alcohol Administration Act, which is filed with or acted on by (1) the...

26 CFR 601.522 - Power of attorney.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (Machine Guns, Destructive Devices, and Certain Other Firearms), Internal Revenue Code, title 1 of the Gun Control Act of 1968, or the Federal Alcohol Administration Act, which is filed with or acted on by (1) the...

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

Code of Federal Regulations, 2010 CFR

2010-04-01

....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”. ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for processing, repacking, or...

77 FR 14989 - Medicare Program; Revisions to the Durable Medical Equipment, Prosthetics, Orthotics, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-14

... wheelchairs. Prosthetic devices are included in the definition of ``medical and other health services'' in section 1861(s)(8) of the Act. Prosthetic devices are defined as devices (other than dental) which replace... examples of prosthetic devices include cardiac pacemakers, cochlear implants, electrical continence aids...

78 FR 25273 - Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

... Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on... Act Declaration for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on December 17, 2008. Notice of the EUAs...

75 FR 49502 - Medical Device User Fee Act; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-13

... Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the...)) requires that, before FDA begins negotiations with the regulated industry on user fee reauthorization, we...

78 FR 66746 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-06

...] Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2014... and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency will... documents, FDA has committed to updating its Web site in a timely manner to reflect the Agency's review of...

Remote Adaptive Communication System

DTIC Science & Technology

2001-10-25

manage several different devices using the software tool A. Client /Server Architecture The architecture we are proposing is based on the Client ...Server model (see figure 3). We want both client and server to be accessible from anywhere via internet. The computer, acting as a server, is in...the other hand, each of the client applications will act as sender or receiver, depending on the associated interface: user interface or device

Synthesis of securement device options and strategies

DOT National Transportation Integrated Search

2002-03-01

The Americans with Disabilities Act of 1990 (ADA) requires that public transit vehicles be equipped with securement location(s) and device(s) that are able to secure common wheelchairs," as defined in the ADA regulations. The definition and size spec...

Comparison of 4-Layer Bandages and an Adaptive Compression Therapy Device on Intended Pressure Delivery.

PubMed

Mayrovitz, Harvey N; Partsch, Hugo; Vanscheidt, Wolfgang

2015-01-01

To characterize and compare interface pressure profiles of an adaptive compression therapy (ACT) device and a traditional 4-layer bandage (4LB) system. A prospective, randomized, open-label, 1-arm, active controlled study. The sample comprised 12 healthy volunteers. Subjects wore both devices for 8 hours on 3 consecutive days. Treatments were randomized to left and right legs. One clinician performed all applications and was experienced in the clinical use of both devices. Pressures were measured in seated and standing positions at the lower, mid, and upper calf immediately post application and after 1, 4, and 8 hours. Pressures achieved with the ACT were closer to targeted 40/30/20 mmHg graduated pressure values and were significantly less than the 4LB for corresponding sites/postures (P < .001). In the seated position, initial interface pressures (mean ± SD) for the ACT were 36.9 ± 4.9, 30.5 ± 4.5, and 21.0 ± 3.6 mmHg. Corresponding interface pressures for the 4LB were 52.5 ± 8.4, 57.5 ± 10.3, and 53.5 ± 12.9 mmHg. In the standing position, initial interface pressures for the ACT were 40.7 ± 4.8, 35.6 ± 4.5, and 21.1 ± 4.6 compared to 54.6 ± 12.5, 64.4 ± 10.9, and 53.7 ± 14.3 for the 4LB. At 1, 4, and 8 hours after application, the 4LB showed a significant progressive decline in interface pressure in both seated and standing positions (P < .001). Conversely, the ACT did not decrease over time and there was a slight but significant increase for lower and mid-calf sites in the seated position (P < .001). The ACT device provided more consistent interface pressures than the 4LB and the pressures achieved were consistent with contemporary venous ulcer therapy standards.

Not so ugly after all: when shame acts as a commitment device.

PubMed

de Hooge, Ilona E; Breugelmans, Seger M; Zeelenberg, Marcel

2008-10-01

Most psychological theories and research on shame focus on the ugly aspects and negative consequences of this emotion. Theories on moral emotions, however, assume that shame acts as a commitment device motivating prosocial behavior. To solve this apparent paradox, the authors studied the effects of shame on prosocial behavior. Shame was hypothesized to motivate prosocial behavior when it was relevant for the decision at hand (endogenous). In contrast, shame that was not relevant for the decision at hand (exogenous) was hypothesized to have no such effects. Four experiments with three different shame inductions and two different measures of prosocial behavior confirmed that endogenous shame motivated prosocial behavior for proselfs but that exogenous shame did not. Shame is shown to have a clear interpersonal function in the sense that it acts as a commitment device.

21 CFR 860.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE...) of the act with respect to the classification and reclassification of devices intended for human use... information submitted to classification panels or to the Commissioner in connection with classification and...

21 CFR 860.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE...) of the act with respect to the classification and reclassification of devices intended for human use... information submitted to classification panels or to the Commissioner in connection with classification and...

Some green for some green in West Virginia: An overview of the West Virginia Conservation and Preservation Easements Act

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1997-11-01

The West Virginia Conservation and Preservation Act is a land management device whose time has come in West Virginia. Wise use of this tool by lawyers, property owners and holding entities can help the state to achieve a balance between the wise use of its natural resources and the promotion of tourism. Although not appropriate in every situation where it could potentially be applied, the West Virginia Act is a device by which economic and environmental interests can converge for the benefit of both parties.

12 CFR 21.21 - Procedures for monitoring Bank Secrecy Act (BSA) compliance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 1 2012-01-01 2012-01-01 false Procedures for monitoring Bank Secrecy Act (BSA... MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Procedures for Monitoring Bank Secrecy Act Compliance § 21.21 Procedures for monitoring Bank...

12 CFR 21.21 - Procedures for monitoring Bank Secrecy Act (BSA) compliance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 1 2013-01-01 2013-01-01 false Procedures for monitoring Bank Secrecy Act (BSA... MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Procedures for Monitoring Bank Secrecy Act Compliance § 21.21 Procedures for monitoring Bank...

12 CFR 21.21 - Procedures for monitoring Bank Secrecy Act (BSA) compliance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 1 2014-01-01 2014-01-01 false Procedures for monitoring Bank Secrecy Act (BSA... MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Procedures for Monitoring Bank Secrecy Act Compliance § 21.21 Procedures for monitoring Bank...

12 CFR 21.21 - Procedures for monitoring Bank Secrecy Act (BSA) compliance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 1 2011-01-01 2011-01-01 false Procedures for monitoring Bank Secrecy Act (BSA... MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Procedures for Monitoring Bank Secrecy Act Compliance § 21.21 Procedures for monitoring Bank...

12 CFR 21.21 - Procedures for monitoring Bank Secrecy Act (BSA) compliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Procedures for monitoring Bank Secrecy Act (BSA... MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Procedures for Monitoring Bank Secrecy Act Compliance § 21.21 Procedures for monitoring Bank...

An acoustic charge transport imager for high definition television applications

NASA Technical Reports Server (NTRS)

Hunt, William D.; Brennan, Kevin F.; Summers, Christopher J.

1993-01-01

This report covers: (1) invention of a new, ultra-low noise, low operating voltage APD which is expected to offer far better performance than the existing volume doped APD device; (2) performance of a comprehensive series of experiments on the acoustic and piezoelectric properties of ZnO films sputtered on GaAs which can possibly lead to a decrease in the required rf drive power for ACT devices by 15dB; (3) development of an advanced, hydrodynamic, macroscopic simulator used for evaluating the performance of ACT and CTD devices and aiding in the development of the next generation of devices; (4) experimental development of CTD devices which utilize a p-doped top barrier demonstrating charge storage capacity and low leakage currents; (5) refinements in materials growth techniques and in situ controls to lower surface defect densities to record levels as well as increase material uniformity and quality.

78 FR 9349 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

... MR incompatibility or the conditions for safe use in an MR environment. Labeling will mitigate the... Amendments of 1976 (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and the Food and...) and nonclinical testing evaluating the compatibility of the device in a MR environment. In addition...

76 FR 15368 - Minimum Security Devices and Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-21

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision Minimum Security Devices and Procedures... concerning the following information collection. Title of Proposal: Minimum Security Devices and Procedures... establish a written security program is necessitated by the Bank Protection Act (12 U.S.C. 1881-1884), which...

Fast-acting nuclear reactor control device

DOEpatents

Kotlyar, Oleg M.; West, Phillip B.

1993-01-01

A fast-acting nuclear reactor control device for moving and positioning a fety control rod to desired positions within the core of the reactor between a run position in which the safety control rod is outside the reactor core, and a shutdown position in which the rod is fully inserted in the reactor core. The device employs a hydraulic pump/motor, an electric gear motor, and solenoid valve to drive the safety control rod into the reactor core through the entire stroke of the safety control rod. An overrunning clutch allows the safety control rod to freely travel toward a safe position in the event of a partial drive system failure.

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

PubMed

1991-10-10

The Commissioner of Food and Drugs is redelegating authorities to certain officials of the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) to temporarily suspend premarket approval applications and to recall devices in the event those devices would cause serious adverse consequences to health or death. These authorities were given to the FDA by the Safe Medical Devices Act of 1990.

77 FR 8879 - Agency Information Collection Activities; Proposed Collection; Comment Request: Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-15

... Separator Device Operating by Centrifugal or Filtration Separation Principle AGENCY: Food and Drug... automated blood cell separator device operating by centrifugal or filtration separation principle. DATES... Filtration Separation Principle (OMB Control Number 0910-0594)--Extension Under the Safe Medical Devices Act...

75 FR 57801 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-22

...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Third... ``Medical Devices Third- Party Review under the Food and Drug Administration Modernization Act of 1997... that members of the public submit reports, keep records, or provide information to a third party...

76 FR 71041 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-16

... techniques, when appropriate, and other forms of information technology. Medical Device Recall Authority--21...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall... information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required...

12 CFR 326.8 - Bank Secrecy Act compliance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Bank Secrecy Act compliance. 326.8 Section 326.8 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION REGULATIONS AND STATEMENTS OF GENERAL POLICY MINIMUM SECURITY DEVICES AND PROCEDURES AND BANK SECRECY ACT 1 COMPLIANCE Procedures for...

12 CFR 326.8 - Bank Secrecy Act compliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Bank Secrecy Act compliance. 326.8 Section 326.8 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION REGULATIONS AND STATEMENTS OF GENERAL POLICY MINIMUM SECURITY DEVICES AND PROCEDURES AND BANK SECRECY ACT 1 COMPLIANCE Procedures for...

Medtronic, Inc.; premarket approval of the Interstim Sacral Nerve Stimulation (SNS) System--FDA. Notice.

PubMed

1998-01-29

The Food and Drug Administration (FDA) is announcing its approval of the application by Medtronic, Inc., Minneapolis, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Interstim Sacral Nerve Stimulation (SNS) System. After reviewing the recommendation of the Gastroenterology and Urology Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 29, 1997, of the approval of the application.

21 CFR 861.20 - Summary of standards development process.

Code of Federal Regulations, 2010 CFR

2010-04-01

... accordance with section 513(e) of the act to reclassify the device; or (3) Take other appropriate action. [57... (CONTINUED) MEDICAL DEVICES PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT Procedures for Performance... which a performance standard for a device may be established, amended, or revoked is as follows: (a) The...

16 CFR 1507.3 - Fuses.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.3 Fuses. (a) Fireworks devices that require a fuse shall: (1) Utilize only a fuse that has been... it will support either the weight of the fireworks device plus 8 ounces of dead weight or double the...

77 FR 30368 - Defense Federal Acquisition Regulation Supplement; Utilization of Domestic Photovoltaic Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-22

... objective of the rule is to promote utilization of domestic photovoltaic devices under energy savings... 0750-AH43 Defense Federal Acquisition Regulation Supplement; Utilization of Domestic Photovoltaic... Authorization Act for Fiscal Year 2011. The section provides that photovoltaic devices to be utilized in...

GAS DISCHARGE DEVICES

DOEpatents

Arrol, W.J.; Jefferson, S.

1957-08-27

The construction of gas discharge devices where the object is to provide a gas discharge device having a high dark current and stabilized striking voltage is described. The inventors have discovered that the introduction of tritium gas into a discharge device with a subsequent electrical discharge in the device will deposit tritium on the inside of the chamber. The tritium acts to emit beta rays amd is an effective and non-hazardous way of improving the abovementioned discharge tube characteristics

12 CFR 205.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... device means a card, code, or other means of access to a consumer's account, or any combination thereof... of the consumer's wages, salary, or other employee compensation (such as commissions), are made on a... agreement. (c) Act means the Electronic Fund Transfer Act (title IX of the Consumer Credit Protection Act...

75 FR 35447 - Buy American Exception Under the American Recovery and Reinvestment Act of 2009; Nationwide...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

... Reinvestment and Recovery Act of 2009 (Recovery Act) to EERE-funded projects for non-residential programmable...[hyphen]residential programmable thermostats; commercial scale fully-automatic wood pellet boiler systems...) Programmable Thermostats--Includes devices that permit adjustment of heating or air-conditioning operations...

On-chip integration of suspended InGaN/GaN multiple-quantum-well devices with versatile functionalities.

PubMed

Cai, Wei; Yang, Yongchao; Gao, Xumin; Yuan, Jialei; Yuan, Wei; Zhu, Hongbo; Wang, Yongjin

2016-03-21

We propose, fabricate and demonstrate on-chip photonic integration of suspended InGaN/GaN multiple quantum wells (MQWs) devices on the GaN-on-silicon platform. Both silicon removal and back wafer etching are conducted to obtain membrane-type devices, and suspended waveguides are used for the connection between p-n junction InGaN/GaN MQWs devices. As an in-plane data transmission system, the middle p-n junction InGaN/GaN MQWs device is used as a light emitting diode (LED) to deliver signals by modulating the intensity of the emitted light, and the other two devices act as photodetectors (PDs) to sense the light guided by the suspended waveguide and convert the photons into electrons, achieving 1 × 2 in-plane information transmission via visible light. Correspondingly, the three devices can function as independent PDs to realize multiple receivers for free space visible light communication. Further, the on-chip photonic platform can be used as an active electro-optical sensing system when the middle device acts as a PD and the other two devices serve as LEDs. The experimental results show that the auxiliary LED sources can enhance the amplitude of the induced photocurrent.

What Are the Different Types of Contraception?

MedlinePlus

... certain diseases. Long-Acting Reversible Contraception (LARC) Intrauterine Methods An intrauterine device (IUD), also known as an ... in clinical development. Hormonal Methods Short-Acting Hormonal Methods Hormonal methods of birth control use hormones to ...

Self-charging metering and dispensing device for fluids

NASA Technical Reports Server (NTRS)

Hooper, S. L.; Setzer, D. (Inventor)

1984-01-01

A self-metering and dispensing device for fluids obtained from a pressurized fluid supply is discussed. Tubing and valving means permit the introduction of fluid into and discharge from a closed cylindrical reservoir. The reservoir contains a slideably disposed piston co-acting with a coil compression spring, with piston travel determining the amount of fluid in the reservoir. Once the determined amount of fluid is introduced into the reservoir, the fluid is discharged by the force of the coil compression spring acting upon the piston.

21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

75 FR 27264 - Video Device Competition; Implementation of Section 304 of the Telecommunications Act of 1996...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-14

... and Consumer Electronics Equipment AGENCY: Federal Communications Commission. ACTION: Notice of... explore the potential for allowing any electronics manufacturer to offer smart video devices at retail...

Assessment of Detectable Warning Devices for Specification Compliance or Equivalent Facilitation

DOT National Transportation Integrated Search

1992-12-01

This report evaluates the Americans with Disabilities Act Accessibility Guidelines (ADAAG) specification for detectable : warnings and the applicability of equivalent facilitation to the development of detectable warning devices. Ambiguities : in the...

The Effectiveness of Video Tutorials for Teaching Preservice Educators to Use Assistive Technologies

ERIC Educational Resources Information Center

Van Laarhoven, Toni; Munk, Dennis D.; Zurita, Leslie M.; Lynch, Kathleen; Zurita, Brian; Smith, Thomas; Chandler, Lynette

2009-01-01

Students with disabilities are guaranteed access to assistive technologies (AT) by provisions of the Individuals with Disabilities Education Improvement Act (IDEIA) (2004) and its predecessor, the Technology Related Assistance Act (Tech Act) (1988). Design and development of AT, including devices and software programs, has burgeoned to a point…

21 CFR 861.1 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment... controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance...

21 CFR 861.1 - Purpose and scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment... controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance...

21 CFR 861.1 - Purpose and scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment... controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance...

21 CFR 861.1 - Purpose and scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment... controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance...

21 CFR 861.1 - Purpose and scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment... controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance...

Recovering fraudulent claims for Australian federal expenditure on pharmaceuticals and medical devices.

PubMed

Faunce, Thomas; Urbas, Gregor; Skillen, Lesley; Smith, Marc

2010-12-01

The Australian Federal Government expends increasingly large amounts of money on pharmaceuticals and medical devices. It is likely, given government experience in other jurisdictions, that a significant proportion of this expenditure is paid as a result of fraudulent claims presented by corporations. In the United States, legislation such as the False Claims Act 1986 (US), the Fraud Enforcement and Recovery Act 2009 (US), the Stark (Physician Self-Referral) Statute 1995 (US), the Anti-Kickback Statute 1972 (US), the Food, Drug and Cosmetic Act 1938 (US), the Social Security Act 1965 (US), and the Patient Protection and Affordable Care Act 2010 (US) has created systematic processes allowing the United States Federal Government to recover billions of dollars in fraudulently made claims in the health and procurement areas. The crucial component involves the creation of financial incentives for information about fraud to be revealed from within the corporate sector to the appropriate state officials. This article explores the opportunities for creating a similar system in Australia in the health care setting.

TU-AB-204-04: Partnerships

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ochs, R.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

77 FR 74197 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-13

... section entitled ``Agenda'', the product name ``NeuroPace Responsive Neurostimulation (RNS) System'' is corrected to read ``NeuroPace RNS System''. Dated: December 7, 2012. Jill Hartzler Warner, Acting Associate...

Compliance Assurance Monitoring Technical Guidance Document Appendix A: Condenser Control Device

EPA Pesticide Factsheets

Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

76 FR 256 - Informed Consent Elements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-04

... societies, trade organizations representing clinical research organizations, drug and device sponsors, blood banks, clinical research organizations, research hospitals, medical device manufacturers, nonprofit... Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to...

7 CFR 54.2 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2010 CFR

2010-01-01

... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) MEATS, PREPARED MEATS, AND MEAT PRODUCTS (GRADING, CERTIFICATION, AND STANDARDS) Regulations Definitions § 54.2 Designation of...

7 CFR 54.2 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2011 CFR

2011-01-01

... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) MEATS, PREPARED MEATS, AND MEAT PRODUCTS (GRADING, CERTIFICATION, AND STANDARDS) Regulations Definitions § 54.2 Designation of...

78 FR 46970 - Medical Device User Fee Rates for Fiscal Year 2014

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

...] Medical Device User Fee Rates for Fiscal Year 2014 AGENCY: Food and Drug Administration, HHS. ACTION... procedures for medical device user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act.... The FY 2014 fee rates are provided in this document. These fees apply from October 1, 2013, through...

Compliance Assurance Monitoring Technical Guidance Document Appendix A: Fabric Filter Control Devices

EPA Pesticide Factsheets

Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

Compliance Assurance Monitoring Technical Guidance Document Appendix A: Wet Electrostatic Precipitator Control Device

EPA Pesticide Factsheets

Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

Compliance Assurance Monitoring Technical Guidance Document Appendix A: Electrostatic Precipitator Control Device

EPA Pesticide Factsheets

Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

Compliance Assurance Monitoring Technical Guidance Document Appendix A: Electrified Filter Bed Control Device

EPA Pesticide Factsheets

Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

Compliance Assurance Monitoring Technical Guidance Document Appendix A: Carbon Adsorber Control Device

EPA Pesticide Factsheets

Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

Barrier breaching device

DOEpatents

Honodel, Charles A.

1985-01-01

A barrier breaching device that is designed primarily for opening holes in interior walls of buildings uses detonating fuse for explosive force. The fuse acts as the ribs or spokes of an umbrella-like device that may be opened up to form a cone. The cone is placed against the wall so that detonating fuse that rings the base of the device and which is ignited by the spoke-like fuses serves to cut a circular hole in the wall.

Storage Reliability of Missile Materiel Program, Monolithic Bipolar SSI/ MSI Digital and Linear Integrated Circuit Analysis

DTIC Science & Technology

1978-01-01

Beam Lead Sealed Junction (ELSJ) devices, the silicon nitride seals the devices from sodium and since the platinum silicide and titanium metals also...improve the surface stability of bipolar devices. These materials act as gettering agents for sodium ions, thus making the contamination far less...electric field, can cause appreciable device parameter instability. Silicon nitride has been shown to be an effective barrier to sodium migration. In

Barrier breaching device

DOEpatents

Honodel, C.A.

1983-06-01

A barrier breaching device that is designed primarily for opening holes in interior walls of buildings uses detonating fuse for explosive force. The fuse acts as the ribs or spokes of an umbrella-like device that may be opened up to form a cone. The cone is placed against the wall so that detonating fuse that rings the base of the device and which is ignited by the spoke-like fuses serves to cut a circular hole in the wall.

iPad integration in plastic surgical training: optimizing clinical efficiency, education, and compliance with the health insurance portability and accountability act.

PubMed

Gerstle, Theodore; Hassanein, Aladdin H; Eriksson, Elof

2015-01-01

The authors share their experience with the issuance of iPads to all residents, faculty, and physician extenders in their plastic surgical division. They found that these devices (1) optimized compliance with the Health Insurance Portability and Accountability Act by eliminating the use of paper service lists; (2) improved clinical efficiency; and (3) promoted resident education. They believe the use of these devices in residency is cost-effective when considering mitigating patient privacy risk and enriching educational value.

7 CFR 56.2 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2011 CFR

2011-01-01

... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) VOLUNTARY GRADING OF SHELL EGGS Grading of Shell Eggs Definitions § 56.2 Designation of official certificates, memoranda, marks...

Compliance Assurance Monitoring Technical Guidance Document Appendix A: Scrubbers for Particulate Matter Control Devices

EPA Pesticide Factsheets

Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

16 CFR 1750.3 - Scope and application.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.3 Scope and application. This standard shall apply to devices furnished with household refrigerators manufactured and...

21 CFR 810.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY General Provisions § 810.2 Definitions. As used in this part: (a) Act..., physical therapists, technologists, or any other practitioners or allied health professionals that have a...

21 CFR 810.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY General Provisions § 810.2 Definitions. As used in this part: (a) Act..., physical therapists, technologists, or any other practitioners or allied health professionals that have a...

21 CFR 810.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY General Provisions § 810.2 Definitions. As used in this part: (a) Act..., physical therapists, technologists, or any other practitioners or allied health professionals that have a...

21 CFR 810.2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY General Provisions § 810.2 Definitions. As used in this part: (a) Act..., physical therapists, technologists, or any other practitioners or allied health professionals that have a...

Compliance Assurance Monitoring Technical Guidance Document Appendix A: Scrubbers for Gaseous Pollutants Control Devices

EPA Pesticide Factsheets

Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

78 FR 42082 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-15

... Request; Agreement for Shipment of Devices for Sterilization AGENCY: Food and Drug Administration, HHS... review and clearance. Agreement for Shipment of Devices for Sterilization--21 CFR 801.150(e) (OMB Control... (the FD&C Act) (21 U.S.C. 351(c) and 352(a)), nonsterile devices that are labeled as sterile but are in...

TU-AB-204-01: Device Approval Process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Delfino, J.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

TU-AB-204-02: Device Adverse Events and Compliance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gonzales, S.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

A simplified modification of a reconstruction plate into a mandibular transport distraction device: A technical note.

PubMed

Mohanty, Sujata; Dabas, Jitender; Gupta, Rekha

2015-01-01

Transport distraction is nowadays gaining enormous popularity and is becoming a promising option for reconstruction of mandibular defects. However, the vast number of distraction device designs create huge confusion in the clinician's mind to choose the right one. Considering these complex and costly designs, the authors decided to find a simplified way of combining a modified conventional reconstruction plate and monofocal distraction device that can act as a transport distraction device for bridging of bony defects. A case performed by this technique and device has been presented along with the description of device design.

21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

75 FR 53723 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 (Pub. L. 95-541)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-01

... Antarctic Conservation Act of 1978 (Pub. L. 95-541), as amended by the Antarctic Science, Tourism and...-depth sensing equipment is available, however positioning such devices near seabird and pinniped...

75 FR 21349 - Notice of Lodging of Consent Decree Under the Clean Air Act and the Emergency Planning and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-23

... Community Right-To-Know Act. The Complaint alleges violations including the burning of diesel fuel with excessive sulfur; operating three diesel generators while air pollution control devices were inoperable...

The Employee Polygraph Protection Act of 1988.

ERIC Educational Resources Information Center

Duffy, Patrick J.

1989-01-01

Aspects of the new Employee Polygraph Protection Act are discussed, including exemptions, prohibited devices, limitations, exceptions, injury and access requirements, reasonable suspicion, drug industry investigations, procedural requirements, disclosure, basis for discharge, enforcement and remedies, and preemption and existing state laws. (MSE)

Single photon detection with self-quenching multiplication

NASA Technical Reports Server (NTRS)

Zheng, Xinyu (Inventor); Cunningham, Thomas J. (Inventor); Pain, Bedabrata (Inventor)

2011-01-01

A photoelectronic device and an avalanche self-quenching process for a photoelectronic device are described. The photoelectronic device comprises a nanoscale semiconductor multiplication region and a nanoscale doped semiconductor quenching structure including a depletion region and an undepletion region. The photoelectronic device can act as a single photon detector or a single carrier multiplier. The avalanche self-quenching process allows electrical field reduction in the multiplication region by movement of the multiplication carriers, thus quenching the avalanche.

Uptake of long-acting reversible contraceptive devices in Western region of The Gambia.

PubMed

Anyanwu, Matthew; Alida, Bom Wekye Ndam

2017-06-01

The contraceptive method has become an essential factor in the life of most women of reproductive age group; although it varies in different stages of their life course. The use of long acting reversible methods (LARC) is proposed as a strategy to reverse undesirable maternal health consequences in developing countries. To determine the uptake of long-acting reversible contraceptive in The Gambia. A community based cross-sectional study of women attending family planning clinic were studied using intervieweradministered questionnaire which included information on socio-demographic factors, reproductive health and contraceptive use of the participants. About 89 % of study participants used long acting reversible contraceptive methods. Of the three commonly available long acting reversible contraceptive methods, Depo Provera was the most commonly used method; 78 of 141 (55.32%); followed by implants (43.3%) and intrauterine contraceptive (1.42%). Being housewives, with 3-4 living children and having secondary level education were associated with high uptake of LARC. The uptake of long acting reversible contraceptive was high; with Depo Provera as the most commonly used contraceptive method in The Gambia. There seemed to be an increase in the uptake of implants; with intrauterine contraceptive device being the least commonly used method.

Interband cascade (IC) photovoltaic (PV) architecture for PV devices

DOEpatents

Yang, Rui Q.; Tian, Zhaobing; Mishima, Tetsuya D.; Santos, Michael B.; Johnson, Matthew B.; Klem, John F.

2015-10-20

A photovoltaic (PV) device, comprising a PV interband cascade (IC) stage, wherein the IC PV stage comprises an absorption region with a band gap, the absorption region configured to absorb photons, an intraband transport region configured to act as a hole barrier, and an interband tunneling region configured to act as an electron barrier. An IC PV architecture for a photovoltaic device, the IC PV architecture comprising an absorption region, an intraband transport region coupled to the absorption region, and an interband tunneling region coupled to the intraband transport region and to the adjacent absorption region, wherein the absorption region, the intraband transport region, and the interband tunneling region are positioned such that electrons will flow from the absorption region to the intraband transport region to the interband tunneling region.

FAST ACTING CURRENT SWITCH

DOEpatents

Batzer, T.H.; Cummings, D.B.; Ryan, J.F.

1962-05-22

A high-current, fast-acting switch is designed for utilization as a crowbar switch in a high-current circuit such as used to generate the magnetic confinement field of a plasma-confining and heat device, e.g., Pyrotron. The device particularly comprises a cylindrical housing containing two stationary, cylindrical contacts between which a movable contact is bridged to close the switch. The movable contact is actuated by a differential-pressure, airdriven piston assembly also within the housing. To absorb the acceleration (and the shock imparted to the device by the rapidly driven, movable contact), an adjustable air buffer assembly is provided, integrally connected to the movable contact and piston assembly. Various safety locks and circuit-synchronizing means are also provided to permit proper cooperation of the invention and the high-current circuit in which it is installed. (AEC)

16 CFR 1750.4 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.4 General requirements. Household refrigerators shall be equipped with a device enabling the doors thereof to be opened...

16 CFR 1750.4 - General requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.4 General requirements. Household refrigerators shall be equipped with a device enabling the doors thereof to be opened...

16 CFR 1750.4 - General requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.4 General requirements. Household refrigerators shall be equipped with a device enabling the doors thereof to be opened...

16 CFR 1750.4 - General requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.4 General requirements. Household refrigerators shall be equipped with a device enabling the doors thereof to be opened...

49 CFR Appendix C to Part 218 - Statement of Agency Enforcement Policy on Tampering

Code of Federal Regulations, 2011 CFR

2011-10-01

... Act, 49 App. U.S.C. 1801 et seq.) Under that statutory language, the responsible members of the crew... train with a disabled device be operated after having learned that the safety device is not functioning...

Summary of Proton Test on the Quick Logic QL3025 at Indiana University

NASA Technical Reports Server (NTRS)

Katz, Richard

1998-01-01

This issue of the Programmable Logic Application Notes is a compilation of topics: (1) Proton irradiation tests were performed on the Quick Logic QL3025 at the Indian University Cyclotron facility. The devices, tests, and results are discussed; (2) The functional failure of EEPROM's in heavy ion environment is presented; (3) the Act 1 architecture is summarized; (4) Antifuse hardness and hardness testing is updated; the single even upset (SEU) response of hardwired flip-flops is also presented; (4) Total dose results of the ACT 2 and ACT 3 circuits is presented in a chart; (5) Recent sub-micron devices testing of total dose is presented in a chart along with brief discussion; and (6) a reference to the WWW site for more articles of interest.

Technology and Children with Disabilities: A Guide for Family Members. P.L. 100-407: Technology-Related Assistance for Individuals with Disabilities Act of 1988. P.L. 100-360: Medicare Catastrophic Coverage Act.

ERIC Educational Resources Information Center

Turnbull, H. Rutherford, III

The booklet describes the provisions and the significance of two laws which provide technology services or devices for persons with disabilities: Public Law 100-407, the Technology Related Assistance for Individuals with Disabilities Act of 1988; and Public Law 100-360, the Medicare Catastrophic Coverage Act. The first authorizes federal funds to…

New, small, fast acting blood glucose meters--an analytical laboratory evaluation.

PubMed

Weitgasser, Raimund; Hofmann, Manuela; Gappmayer, Brigitta; Garstenauer, Christa

2007-09-22

Patients and medical personnel are eager to use blood glucose meters that are easy to handle and fast acting. We questioned whether accuracy and precision of these new, small and light weight devices would meet analytical laboratory standards and tested four meters with the above mentioned conditions. Approximately 300 capillary blood samples were collected and tested using two devices of each brand and two different types of glucose test strips. Blood from the same samples was used for comparison. Results were evaluated using maximum deviation of 5% and 10% from the comparative method, the error grid analysis, the overall deviation of the devices, the linear regression analysis as well as the CVs for measurement in series. Of all 1196 measurements a deviation of less than 5% resp. 10% from the reference method was found for the FreeStyle (FS) meter in 69.5% and 96%, the Glucocard X Meter (GX) in 44% and 75%, the One Touch Ultra (OT) in 29% and 60%, the Wellion True Track (WT) in 28.5% and 58%. The error grid analysis gave 99.7% for FS, 99% for GX, 98% for OT and 97% for WT in zone A. The remainder of the values lay within zone B. Linear regression analysis resembled these results. CVs for measurement in series showed higher deviations for OT and WT compared to FS and GX. The four new, small and fast acting glucose meters fulfil clinically relevant analytical laboratory requirements making them appropriate for use by medical personnel. However, with regard to the tight and restrictive limits of the ADA recommendations, the devices are still in need of improvement. This should be taken into account when the devices are used by primarily inexperienced persons and is relevant for further industrial development of such devices.

45 CFR 160.103 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., the following definitions apply to this subchapter: Act means the Social Security Act. ANSI stands for... required documents. Electronic media means: (1) Electronic storage media including memory devices in computers (hard drives) and any removable/transportable digital memory medium, such as magnetic tape or disk...

45 CFR 160.103 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., the following definitions apply to this subchapter: Act means the Social Security Act. ANSI stands for... required documents. Electronic media means: (1) Electronic storage media including memory devices in computers (hard drives) and any removable/transportable digital memory medium, such as magnetic tape or disk...

45 CFR 160.103 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., the following definitions apply to this subchapter: Act means the Social Security Act. ANSI stands for... required documents. Electronic media means: (1) Electronic storage media including memory devices in computers (hard drives) and any removable/transportable digital memory medium, such as magnetic tape or disk...

The Impact of Interrupted Use of a Speech Generating Device on the Communication Acts of a Child with Autism Spectrum Disorder: A Case Study

ERIC Educational Resources Information Center

Neeley, Richard A.; Pulliam, Mary Hannah; Catt, Merrill; McDaniel, D. Mike

2015-01-01

This case study examined the initial and renewed impact of speech generating devices on the expressive communication behaviors of a child with autism spectrum disorder. The study spanned six years of interrupted use of two speech generating devices. The child's communication behaviors were analyzed from video recordings and included communication…

TU-AB-204-03: Research Activities in Medical Physics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Badano, A.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

7 CFR 28.176 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2010 CFR

2010-01-01

..., other identifications, and devices for purpose of the Agricultural Marketing Act. 28.176 Section 28.176 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE COMMODITY STANDARDS AND STANDARD CONTAINER...

Storage Reliability of Missile Materiel Program. Storage Reliability Analysis Summary Report. Volume 1. Electrical and Electronic Devices

DTIC Science & Technology

1978-01-01

silicon nitride seals the devices from sodium and since the platinum silicide and titanium metals also offer very low mobility to the alkaline ions, the...of bipolar devices. These materials act as gettering agents for sodium ions, thus making the contamination far less mobile. The stability of the...parameter instability. Silicon nitride has been shown to be an effective barrier to sodium migration. In Beam Lead Sealed Junction (BLSJ) devices, the

All linear optical quantum memory based on quantum error correction.

PubMed

Gingrich, Robert M; Kok, Pieter; Lee, Hwang; Vatan, Farrokh; Dowling, Jonathan P

2003-11-21

When photons are sent through a fiber as part of a quantum communication protocol, the error that is most difficult to correct is photon loss. Here we propose and analyze a two-to-four qubit encoding scheme, which can recover the loss of one qubit in the transmission. This device acts as a repeater, when it is placed in series to cover a distance larger than the attenuation length of the fiber, and it acts as an optical quantum memory, when it is inserted in a fiber loop. We call this dual-purpose device a "quantum transponder."

Computers, Technology, and Disability. [Update.

ERIC Educational Resources Information Center

American Council on Education, Washington, DC. HEATH Resource Center.

This paper describes programs and resources that focus on access of postsecondary students with disabilities to computers and other forms of technology. Increased access to technological devices and services is provided to students with disabilities under the Technology-Related Assistance for Individuals with Disabilities Act (Tech Act). Section…

21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... professionals only; (b) The modified device operates using a different fundamental scientific technology than a... therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6...

Rail-Highway Crossing Warning Device Life Cycle Cost Analysis

DOT National Transportation Integrated Search

1980-09-01

The Highway Safety Acts of 1973 and 1976, and the Surface Transportation Assistance Act of 1978 provide funds to individual states to improve safety at public rail-highway crossings. This report was undertaken in support of a U.S. DOT effort to impro...

27 CFR 479.161 - National Firearms Act stamps.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true National Firearms Act stamps. 479.161 Section 479.161 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.161 - National Firearms Act stamps.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false National Firearms Act stamps. 479.161 Section 479.161 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.161 - National Firearms Act stamps.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false National Firearms Act stamps. 479.161 Section 479.161 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.161 - National Firearms Act stamps.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false National Firearms Act stamps. 479.161 Section 479.161 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.161 - National Firearms Act stamps.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2012-04-01 2010-04-01 true National Firearms Act stamps. 479.161 Section 479.161 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

Self-healing fuse

NASA Technical Reports Server (NTRS)

Jones, N. D.; Kinsinger, R. E.; Harris, L. P.

1974-01-01

Fast-acting current limiting device provides current overload protection for vulnerable circuit elements and then re-establishes conduction path within milliseconds. Fuse can also perform as fast-acting switch to clear transient circuit overloads. Fuse takes advantage of large increase in electrical resistivity that occurs when liquid metal vaporizes.

Summary of the Department of Transportation Rail-Highway Crossing Accident Prediction Formulas and Resource Model

DOT National Transportation Integrated Search

1982-09-01

The Highway Safety Acts of 1973 and 1976, and the Surface Transportation Assistance Act of 1978, provide funding authorizations to individual states to improve safety at public rail-highway crossings. The installation of active motorist warning devic...

Electron-beam-induced information storage in hydrogenated amorphous silicon devices

DOEpatents

Yacobi, B.G.

1985-03-18

A method for recording and storing information in a hydrogenated amorphous silicon device, comprising: depositing hydrogenated amorphous silicon on a substrate to form a charge collection device; and generating defects in the hydrogenated amorphous silicon device, wherein the defects act as recombination centers that reduce the lifetime of carriers, thereby reducing charge collection efficiency and thus in the charge collection mode of scanning probe instruments, regions of the hydrogenated amorphous silicon device that contain the defects appear darker in comparison to regions of the device that do not contain the defects, leading to a contrast formation for pattern recognition and information storage.

7 CFR 52.3 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2010 CFR

2010-01-01

..., other identifications, and devices for purposes of the Agricultural Marketing Act. 52.3 Section 52.3 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL...

7 CFR 70.2 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2010 CFR

2010-01-01

..., other identifications, and devices for purposes of the Agricultural Marketing Act. 70.2 Section 70.2 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE...

7 CFR 51.3 - Designation of official certificates, memoranda, marks, other identifications and devices for...

Code of Federal Regulations, 2010 CFR

2010-01-01

..., other identifications and devices for purposes of the Agricultural Marketing Act. 51.3 Section 51.3 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL...

50 CFR 648.146 - Special management zones.

Code of Federal Regulations, 2010 CFR

2010-10-01

... for an artificial reef, fish attraction device, or other modification of habitat for purposes of... that are not compatible with the intent of the artificial reef or fish attraction device or other... Magnuson-Stevens Act, and other applicable law. (5) The natural bottom in and surrounding potential SMZs...

16 CFR § 1750.4 - General requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

...§ 1750.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.4 General requirements. Household refrigerators shall be equipped with a device enabling the doors thereof to be opened...

12 CFR 21.3 - Security program.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 1 2014-01-01 2014-01-01 false Security program. 21.3 Section 21.3 Banks and Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Minimum Security Devices and...

12 CFR 21.3 - Security program.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 1 2013-01-01 2013-01-01 false Security program. 21.3 Section 21.3 Banks and Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Minimum Security Devices and...

12 CFR 21.3 - Security program.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 1 2011-01-01 2011-01-01 false Security program. 21.3 Section 21.3 Banks and Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Minimum Security Devices and...

Passive dual spin misalignment compensators. [gyrostabilized device

NASA Technical Reports Server (NTRS)

Donohue, J. H.; Zimmerman, B. G. (Inventor)

1974-01-01

A combination dual-spin gyroscopically stabilized device is described having a spinning rotor and a non-spinning platform. Two substantially lossless mechanical resonators, resonant at the spin frequency, are orthogonally positioned on the platform for compensation for the disturbing torque acting on the platform due to rotor misalignment.

Low cost microfluidic device based on cotton threads for electroanalytical application.

PubMed

Agustini, Deonir; Bergamini, Márcio F; Marcolino-Junior, Luiz Humberto

2016-01-21

Microfluidic devices are an interesting alternative for performing analytical assays, due to the speed of analyses, reduced sample, reagent and solvent consumption and less waste generation. However, the high manufacturing costs still prevent the massive use of these devices worldwide. Here, we present the construction of a low cost microfluidic thread-based electroanalytical device (μTED), employing extremely cheap materials and a manufacturing process free of equipment. The microfluidic channels were built with cotton threads and the estimated cost per device was only $0.39. The flow of solutions (1.12 μL s(-1)) is generated spontaneously due to the capillary forces, eliminating the use of any pumping system. To demonstrate the analytical performance of the μTED, a simultaneous determination of acetaminophen (ACT) and diclofenac (DCF) was performed by multiple pulse amperometry (MPA). A linear dynamic range (LDR) of 10 to 320 μmol L(-1) for both species, a limit of detection (LOD) and a limit of quantitation (LOQ) of 1.4 and 4.7 μmol L(-1) and 2.5 and 8.3 μmol L(-1) for ACT and DCF, respectively, as well as an analytical frequency of 45 injections per hour were reached. Thus, the proposed device has shown potential to extend the use of microfluidic analytical devices, due to its simplicity, low cost and good analytical performance.

Nano-Localized Thermal Analysis and Mapping of Surface and Sub-Surface Thermal Properties Using Scanning Thermal Microscopy (SThM).

PubMed

Pereira, Maria J; Amaral, Joao S; Silva, Nuno J O; Amaral, Vitor S

2016-12-01

Determining and acting on thermo-physical properties at the nanoscale is essential for understanding/managing heat distribution in micro/nanostructured materials and miniaturized devices. Adequate thermal nano-characterization techniques are required to address thermal issues compromising device performance. Scanning thermal microscopy (SThM) is a probing and acting technique based on atomic force microscopy using a nano-probe designed to act as a thermometer and resistive heater, achieving high spatial resolution. Enabling direct observation and mapping of thermal properties such as thermal conductivity, SThM is becoming a powerful tool with a critical role in several fields, from material science to device thermal management. We present an overview of the different thermal probes, followed by the contribution of SThM in three currently significant research topics. First, in thermal conductivity contrast studies of graphene monolayers deposited on different substrates, SThM proves itself a reliable technique to clarify the intriguing thermal properties of graphene, which is considered an important contributor to improve the performance of downscaled devices and materials. Second, SThM's ability to perform sub-surface imaging is highlighted by thermal conductivity contrast analysis of polymeric composites. Finally, an approach to induce and study local structural transitions in ferromagnetic shape memory alloy Ni-Mn-Ga thin films using localized nano-thermal analysis is presented.

Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.

PubMed

1998-11-03

The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).

Device-identified atrial fibrillation at pacing clinics. Should it guide anticoagulation?

PubMed

Merinopoulos, Ioannis; Raphael, Claire E; Yardley, Alaina; Goonewardene, Manoj; Vassiliou, Vassilios S

2016-03-15

In recent years, there has been a significant increase in the number of devices implanted following improvement in their safety profile, extension of indications and reduction in cost. Although the reason remains largely the beneficial effect on heart rhythm stabilisation, implanted devices might also have additional advantages, notably identification of silent arrhythmia. Should clinicians therefore act on device-identified atrial fibrillation (AF) and should such identification be used to guide anticoagulation management? This review evaluates the current evidence on the management of device-identified asymptomatic AF. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Giant electron-hole transport asymmetry in ultra-short quantum transistors.

PubMed

McRae, A C; Tayari, V; Porter, J M; Champagne, A R

2017-05-31

Making use of bipolar transport in single-wall carbon nanotube quantum transistors would permit a single device to operate as both a quantum dot and a ballistic conductor or as two quantum dots with different charging energies. Here we report ultra-clean 10 to 100 nm scale suspended nanotube transistors with a large electron-hole transport asymmetry. The devices consist of naked nanotube channels contacted with sections of tube under annealed gold. The annealed gold acts as an n-doping top gate, allowing coherent quantum transport, and can create nanometre-sharp barriers. These tunnel barriers define a single quantum dot whose charging energies to add an electron or a hole are vastly different (e-h charging energy asymmetry). We parameterize the e-h transport asymmetry by the ratio of the hole and electron charging energies η e-h . This asymmetry is maximized for short channels and small band gap tubes. In a small band gap device, we demonstrate the fabrication of a dual functionality quantum device acting as a quantum dot for holes and a much longer quantum bus for electrons. In a 14 nm-long channel, η e-h reaches up to 2.6 for a device with a band gap of 270 meV. The charging energies in this device exceed 100 meV.

21 CFR 820.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... used in, and the facilities and controls used for, the design, manufacture, packaging, labeling... compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements... controls apply only to those devices listed in § 820.30(a)(2). This regulation does not apply to...

21 CFR 820.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... used in, and the facilities and controls used for, the design, manufacture, packaging, labeling... compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements... controls apply only to those devices listed in § 820.30(a)(2). This regulation does not apply to...

21 CFR 820.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... used in, and the facilities and controls used for, the design, manufacture, packaging, labeling... compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements... controls apply only to those devices listed in § 820.30(a)(2). This regulation does not apply to...

21 CFR 820.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... used in, and the facilities and controls used for, the design, manufacture, packaging, labeling... compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements... controls apply only to those devices listed in § 820.30(a)(2). This regulation does not apply to...

27 CFR 479.193 - Arms Export Control Act.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Arms Export Control Act. 479.193 Section 479.193 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND...

27 CFR 479.193 - Arms Export Control Act.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2012-04-01 2010-04-01 true Arms Export Control Act. 479.193 Section 479.193 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND...

27 CFR 479.193 - Arms Export Control Act.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true Arms Export Control Act. 479.193 Section 479.193 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND...

27 CFR 479.193 - Arms Export Control Act.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false Arms Export Control Act. 479.193 Section 479.193 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND...

27 CFR 479.193 - Arms Export Control Act.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Arms Export Control Act. 479.193 Section 479.193 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND...

Observational learning without a model is influenced by the observer's possibility to act: evidence from the Simon task.

PubMed

Iani, Cristina; Rubichi, Sandro; Ferraro, Luca; Nicoletti, Roberto; Gallese, Vittorio

2013-07-01

We assessed whether observational learning in perceptual-motor tasks is affected by the visibility of an action producing perceived environmental effects and by the observer's possibility to act during observation. To this end, we conducted three experiments in which participants were required to observe a spatial compatibility task in which only the effects of computer-generated responses were visible before executing a Simon task. In Experiment 1, we compared the effects of a passively observed practice with either a spatially compatible or incompatible stimulus-response (S-R) association. In Experiment 2, during the observed spatially incompatible practice participants were prevented from potentially acting, either because a plexiglas barrier separated the participant from the response device rendering it out of reach; or because the participant's hands were tied; or the device affording a response was absent. In Experiment 3, the plexiglas presented an opening that could allow the participant to potentially reach and interact with it. As when the practice is physically performed, we found an elimination of the Simon effect following a spatially incompatible observed practice, suggesting that participants learned an incompatible S-R association by observing and transferred this knowledge to the subsequent Simon task. No evidence of transfer of learning was found when, during passive observation, the participant's hands were tied, or a barrier prevented him/her from potentially interacting with the device, or no response device was present. Differently, a transfer-of-learning effect was observed when the barrier presented an opening. These results suggest that learning can derive from the mere observation of action effects, even when an action is not visible, as long as the observer has the potential to act. Copyright © 2013 Elsevier B.V. All rights reserved.

75 FR 20441 - Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-19

...The Food and Drug Administration (FDA) is announcing the issuance of 10 Emergency Use Authorizations (EUAs) (the Authorizations) several of which were amended after initial issuance, for certain in vitro diagnostic devices. FDA also is announcing an amendment to the EUA for the Centers for Disease Control and Prevention (CDC) Swine Influenza Virus Real-time RT-PCR Detection Panel authorized on April 27, 2009. FDA is issuing the Authorizations and amendments thereto under the Federal Food, Drug, and Cosmetic Act (the act). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostics. The Authorizations follow the determination by the Acting Secretary of the U.S. Department of Health and Human Services, Charles E. Johnson (the Acting Secretary), that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A, or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics, accompanied by emergency use information subject to the terms of any authorization issued under the Federal Food, Drug, and Cosmetic Act (the act). The Authorizations, which include explanations of the reasons for their issuance or reissuance, are reprinted in this document.

75 FR 69445 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-12

..., biological agents, medical devices and brachytherapy devices. Section 402 of the Benefits Improvement and...) of the Act. Frequency: Once; Affected Public: Private Sector: Business or other for-profits; Number... PPS Transition Election and attestations of Low-Volume; Form Number: CMS-10351 (OMB : 0938-New); Use...

16 CFR Figure 2 to Part 1508 - Headform Probe

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Headform Probe 2 Figure 2 to Part 1508 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES Multiple-tube fireworks devices. Pt. 1508, Fig. 2 Figure 2 to Part 1508—Headform Probe...

16 CFR Figure 2 to Part 1508 - Headform Probe

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Headform Probe 2 Figure 2 to Part 1508 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES Multiple-tube fireworks devices. Pt. 1508, Fig. 2 Figure 2 to Part 1508—Headform Probe...

16 CFR Figure 2 to Part 1508 - Headform Probe

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Headform Probe 2 Figure 2 to Part 1508 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES Multiple-tube fireworks devices. Pt. 1508, Fig. 2 Figure 2 to Part 1508—Headform Probe...

47 CFR 15.1 - Scope of this part.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.1 Scope of this..., administrative requirements and other conditions relating to the marketing of part 15 devices. (b) The operation... part must be licensed pursuant to the provisions of section 301 of the Communications Act of 1934, as...

77 FR 19937 - Inflatable Personal Flotation Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-03

... Advancement Act OMB Office of Management and Budget PFD Personal flotation device STP Standards Technical... using existing inflatable PFDs, and would enable marketing of existing inflatable PFDs to youth. The... approved, and thus does not affect the availability, use, or marketing of existing PFDs to or by the youth...

77 FR 47028 - Kenai Peninsula-Anchorage Borough Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-07

... Secure Rural Schools and Community Self-Determination Act (Pub. L. 110-343) (the Act) and operates in... language interpreting, assistive listening devices or other reasonable accommodation for access to the.../fsfiles/unit/wo/secure_rural_schools.nsf . Anyone who would like to bring related matters to the attention...

16 CFR 1750.2 - Transfer of functions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.2 Transfer of functions. Effective May 14, 1973, section 30(c) of the Consumer Product Safety Act (86 Stat. 1231; 15 U.S.C...

16 CFR § 1750.2 - Transfer of functions.

Code of Federal Regulations, 2013 CFR

2013-01-01

...§ 1750.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.2 Transfer of functions. Effective May 14, 1973, section 30(c) of the Consumer Product Safety Act (86 Stat...

16 CFR 1750.2 - Transfer of functions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.2 Transfer of functions. Effective May 14, 1973, section 30(c) of the Consumer Product Safety Act (86 Stat. 1231; 15 U.S.C...

16 CFR 1750.2 - Transfer of functions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.2 Transfer of functions. Effective May 14, 1973, section 30(c) of the Consumer Product Safety Act (86 Stat. 1231; 15 U.S.C...

16 CFR 1750.2 - Transfer of functions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.2 Transfer of functions. Effective May 14, 1973, section 30(c) of the Consumer Product Safety Act (86 Stat. 1231; 15 U.S.C...

27 CFR 479.101 - Registration of firearms.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND... period established under section 207 of the Gun Control Act of 1968 (82 Stat. 1235). (c) A person shown... the possessors thereof under the provisions of section 207 of the Gun Control Act of 1968. (e) A...

27 CFR 479.101 - Registration of firearms.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND... period established under section 207 of the Gun Control Act of 1968 (82 Stat. 1235). (c) A person shown... the possessors thereof under the provisions of section 207 of the Gun Control Act of 1968. (e) A...

27 CFR 479.101 - Registration of firearms.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND... period established under section 207 of the Gun Control Act of 1968 (82 Stat. 1235). (c) A person shown... the possessors thereof under the provisions of section 207 of the Gun Control Act of 1968. (e) A...

27 CFR 479.101 - Registration of firearms.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND... period established under section 207 of the Gun Control Act of 1968 (82 Stat. 1235). (c) A person shown... the possessors thereof under the provisions of section 207 of the Gun Control Act of 1968. (e) A...

27 CFR 479.101 - Registration of firearms.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND... period established under section 207 of the Gun Control Act of 1968 (82 Stat. 1235). (c) A person shown... the possessors thereof under the provisions of section 207 of the Gun Control Act of 1968. (e) A...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-28

... section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d......... Dako Denmark A/S..... HercepTest kit Approved October 20, 2010. P080009 Ethicon Endo-Surgery, SEDASYS...

Social Learning Theory of Aggression.

ERIC Educational Resources Information Center

Bandura, Albert

1978-01-01

Suggests that violent activities occur not because of reduced self-control, but because cognitive skills and self-control are used through moral justifications and self-exonerative devices in the service of destructive causes. Threats to human welfare are generally brought about by deliberate acts of principle rather than by unrestrained acts of…

21 CFR 807.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Definitions. 807.3 Section 807.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... Provisions § 807.3 Definitions. (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) Commercial...

21 CFR 807.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Definitions. 807.3 Section 807.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... Provisions § 807.3 Definitions. (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) Commercial...

77 FR 36290 - Renewal of Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-18

... information that is necessary to implement two provisions of the Federal Cave Resources Protection Act--one.... Persons who use a telecommunication device for the deaf (TDD) may call the Federal Information Relay... Cave Resources Protection Act (16 U.S.C. 4301-4310). Frequency of Collection: On occasion. Estimated...

A bolus/basal multiple injection regimen in type I diabetes. A multicentre trial using a new 'fountain-pen' device for short-acting human insulin as well as long-acting human insulin.

PubMed

Distiller, L A; Robertson, L I; Moore, R; Bonnici, F

1987-06-20

A trial was undertaken to ascertain the effect and acceptability of a multiple insulin injection regimen (MII) in patients with insulin-dependent diabetes mellitus using short-acting monocomponent human soluble insulin (Actrapid HM; Novo) for pre-meal bolus injections with the NovoPen injection device (Novo) and long-acting human insulin (Ultratard HM; Novo) at bedtime. Fifty-four patients, all previously on twice-daily short/intermediate-acting human insulin (Monotard HM; Novo) and Actrapid HM, were randomly selected. There was a significant overall improvement in diabetic control over the 12 weeks of the trial, the glycosylated haemoglobin (Hb A1) dropping from a mean of 9.8 +/- 2.2% to 8.6 +/- 1.7% (P less than 0.05). MII, using the NovoPen, was found to be more convenient than conventional insulin administration by 92% of the subjects. It is concluded that the NovoPen is a useful and convenient means of administering pre-meal boluses in an MII regimen, with a very high rate of acceptance by patients of all ages.

Design and Development of Smart Medicine Box

NASA Astrophysics Data System (ADS)

Rosli, Ekbal; Husaini, Yusnira

2018-03-01

The Smart Medicine Box is successfully designed in helping the introvert patients taking their medicine without help of others. This project is to develop a robotic device that can assist patient to take medicine alone by implementing an IOT apps system for controlling the Smart Medicine Box where it will overcome an emotional disturbance experience by the introvert patients. There are four sensors such as PIR, IR, temperature and ultrasonic sensors use for the project. The purpose of PIR sensor is to detect hand movement near the device, while IR sensor is to detect the line follower on the floor. The LM 35 acts as the detection of the temperature inside the box and the ultrasonic acts as the detection of the obstacle in front of the device. The MIT Apps Invention 2 is used to develop an apps and collect the data from sensors through Arduino microcontroller. A proof of concept design has implemented and demonstrated successfully.

Characterization of simple wireless neurostimulators and sensors.

PubMed

Gulick, Daniel W; Towe, Bruce C

2014-01-01

A single diode with a wireless power source and electrodes can act as an implantable stimulator or sensor. We have built such devices using RF and ultrasound power coupling. These simple devices could drastically reduce the size, weight, and cost of implants for applications where efficiency is not critical. However, a shortcoming has been a lack of control: any movement of the external power source would change the power coupling, thereby changing the stimulation current or modulating the sensor response. To correct for changes in power and signal coupling, we propose to use harmonic signals from the device. The diode acts as a frequency multiplier, and the harmonics it emits contain information about the drive level and bias. A simplified model suggests that estimation of power, electrode bias, and electrode resistance is possible from information contained in radiated harmonics even in the presence of significant noise. We also built a simple RF-powered stimulator with an onboard voltage limiter.

High-speed low-power photonic transistor devices based on optically-controlled gain or absorption to affect optical interference.

PubMed

Huang, Yingyan; Ho, Seng-Tiong

2008-10-13

We show that a photonic transistor device can be realized via the manipulation of optical interference by optically controlled gain or absorption in novel ways, resulting in efficient transistor signal gain and switching action. Exemplary devices illustrate two complementary device types with high operating speed, microm size, microW switching power, and switching gain. They can act in tandem to provide a wide variety of operations including wavelength conversion, pulse regeneration, and logical operations. These devices could have a Transistor Figure-of-Merits >10(5) times higher than current chi((3)) approaches and are highly attractive.

21 CFR 807.20 - Who must register and submit a device list?

Code of Federal Regulations, 2013 CFR

2013-04-01

..., Drug, and Cosmetic Act or subpart D of this part who is engaged in the manufacture, preparation... establishments under the control of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments. The term “device...

21 CFR 807.20 - Who must register and submit a device list?

Code of Federal Regulations, 2014 CFR

2014-04-01

..., Drug, and Cosmetic Act or subpart D of this part who is engaged in the manufacture, preparation... establishments under the control of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments. The term “device...

77 FR 3159 - Electronic Export Application and Certification Charge; Flexibility in the Requirements for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-23

... Marks, Devices, and Certificates; Egg Products Export Certification AGENCY: Food Safety and Inspection... inspection marks, devices, and certificates. In addition, FSIS is proposing to amend the egg product export... possible under the current system. The Egg Products Inspection Act (EPIA) (21 U.S.C. 1031-1056) does not...

27 CFR 479.93 - Transfers of firearms to certain persons.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES... persons. Where the transfer of a destructive device, machine gun, short-barreled shotgun, or short-barreled rifle is to be made by a person licensed under the provisions of Title I of the Gun Control Act of...

27 CFR 479.93 - Transfers of firearms to certain persons.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES... persons. Where the transfer of a destructive device, machine gun, short-barreled shotgun, or short-barreled rifle is to be made by a person licensed under the provisions of Title I of the Gun Control Act of...

27 CFR 479.93 - Transfers of firearms to certain persons.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES... persons. Where the transfer of a destructive device, machine gun, short-barreled shotgun, or short-barreled rifle is to be made by a person licensed under the provisions of Title I of the Gun Control Act of...

27 CFR 479.93 - Transfers of firearms to certain persons.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES... persons. Where the transfer of a destructive device, machine gun, short-barreled shotgun, or short-barreled rifle is to be made by a person licensed under the provisions of Title I of the Gun Control Act of...

27 CFR 479.93 - Transfers of firearms to certain persons.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES... persons. Where the transfer of a destructive device, machine gun, short-barreled shotgun, or short-barreled rifle is to be made by a person licensed under the provisions of Title I of the Gun Control Act of...

40 CFR 94.1103 - Prohibited acts.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (a)(3)(i) of this section if the action is a necessary and temporary procedure, the device or element is replaced upon completion of the procedure, and the action results in the proper functioning of the... paragraph (a)(3)(i) of this section if the action is a necessary and temporary procedure and the device or...

40 CFR 60.2265 - What definitions must I know?

Code of Federal Regulations, 2012 CFR

2012-07-01

... means an add-on air pollution control device used to capture particulate matter by filtering gas streams... in the air pollution control devices used to comply with the emission limits for the affected CISWI... definitions must I know? Terms used but not defined in this subpart are defined in the Clean Air Act and...

7 CFR 58.2 - Designation of official certificates, memoranda, marks, identifications, and devices for purpose...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Designation of official certificates, memoranda, marks, identifications, and devices for purpose of the Agricultural Marketing Act. 58.2 Section 58.2 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices),...

7 CFR 56.2 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Designation of official certificates, memoranda, marks, other identifications, and devices for purposes of the Agricultural Marketing Act. 56.2 Section 56.2 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices),...

78 FR 55699 - Privacy Act of 1974; Proposed New Systems of Records

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-11

... FMC OIT staff at its Washington, DC headquarters. The FMC GSS is made up of servers, switches, gateways, and two firewall devices. The servers, switches, gateways, and firewall devices are physically... within the confines of FMC-39, FMC General Support System (FMC GSS) and FMC-41, FMC SQL Database (FMCDB...

21 CFR 807.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the... safety and effectiveness of the device. These changes may include, but are not limited to, changes in the... respecting safety and effectiveness) means a summary, submitted under section 513(i) of the act, of the...

78 FR 16533 - Certain Integrated Circuit Devices and Products Containing the Same; Institution of Investigation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-15

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-873] Certain Integrated Circuit Devices.... International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on February 8, 2013, under section 337 of the Tariff Act of...

Photovoltaic devices based on high density boron-doped single-walled carbon nanotube/n-Si heterojunctions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Saini, Viney; Li, Zhongrui; Bourdo, Shawn

2011-01-13

A simple and easily processible photovoltaic device has been developed based on borondoped single-walled carbon nanotubes (B-SWNTs) and n-type silicon (n-Si) heterojunctions. The single-walled carbon nanotubes (SWNTs) were substitutionally doped with boron atoms by thermal annealing, in the presence of B 2O 3. The samples used for these studies were characterized by Raman spectroscopy, thermal gravimetric analysis (TGA), transmission electron microscopy (TEM), and x-ray photoelectron spectroscopy (XPS). The fully functional solar cell devices were fabricated by airbrush deposition that generated uniform B-SWNT films on top of the n-Si substrates. The carbon nanotube films acted as exciton-generation sites, charge collection andmore » transportation, while the heterojunctions formed between B-SWNTs and n-Si acted as charge dissociation centers. The current-voltage characteristics in the absence of light and under illumination, as well as optical transmittance spectrum are reported here. It should be noted that the device fabrication process can be made amenable to scalability by depositing direct and uniform films using airbrushing, inkjet printing, or spin-coating techniques.« less

Assistive acting movement therapy devices with pneumatic rotary-type soft actuators.

PubMed

Wilkening, André; Baiden, David; Ivlev, Oleg

2012-12-01

Inherent compliance and assistive behavior are assumed to be essential properties for safe human-robot interaction. Rehabilitation robots demand the highest standards in this respect because the machine interacts directly with weak persons who are often sensitive to pain. Using novel soft fluidic actuators with rotary elastic chambers (REC actuators), compact, lightweight, and cost-effective therapeutic devices can be developed. This article describes modular design and control strategies for new assistive acting robotic devices for upper and lower extremities. Due to the inherent compliance and natural back-drivability of pneumatic REC actuators, these movement therapy devices provide gentle treatment, whereby the interaction forces between humans and the therapy device are estimated without the use of expensive force/torque sensors. An active model-based gravity compensation based on separated models of the robot and of the individual patient's extremity provides the basis for effective assistive control. The utilization of pneumatic actuators demands a special safety concept, which is merged with control algorithms to provide a sufficient level of safeness and to catch any possible system errors and/or emergency situations. A self-explanatory user interface allows for easy, intuitive handling. Prototypes are very comfortable for use due to several control routines that work in the background. Assistive devices have been tested extensively with several healthy persons; the knee/hip movement therapy device is now under clinical trials at the Clinic for Orthopaedics and Trauma Surgery at the Klinikum Stuttgart.

Optimizing the Usability of Brain-Computer Interfaces.

PubMed

Zhang, Yin; Chase, Steve M

2018-05-01

Brain-computer interfaces are in the process of moving from the laboratory to the clinic. These devices act by reading neural activity and using it to directly control a device, such as a cursor on a computer screen. An open question in the field is how to map neural activity to device movement in order to achieve the most proficient control. This question is complicated by the fact that learning, especially the long-term skill learning that accompanies weeks of practice, can allow subjects to improve performance over time. Typical approaches to this problem attempt to maximize the biomimetic properties of the device in order to limit the need for extensive training. However, it is unclear if this approach would ultimately be superior to performance that might be achieved with a nonbiomimetic device once the subject has engaged in extended practice and learned how to use it. Here we approach this problem using ideas from optimal control theory. Under the assumption that the brain acts as an optimal controller, we present a formal definition of the usability of a device and show that the optimal postlearning mapping can be written as the solution of a constrained optimization problem. We then derive the optimal mappings for particular cases common to most brain-computer interfaces. Our results suggest that the common approach of creating biomimetic interfaces may not be optimal when learning is taken into account. More broadly, our method provides a blueprint for optimal device design in general control-theoretic contexts.

75 FR 75677 - Agency Information Collection Activities; Proposed Collection; Comment Request; Exports...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-06

... requirements for persons exporting human drugs, biological products, devices, animal drugs, food, and cosmetics... Control Number 0910-0482)--Extension The respondents to this information collection are exporters who have... States as allowed under section 801(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S...

78 FR 19510 - Privacy Act of 1974; Republication To Delete and Update Privacy Act System of Records...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-01

... reported under that notice. FOR FURTHER INFORMATION CONTACT: The Chief Privacy Officer, 451 Seventh Street...). (This is not a toll-free number.) A telecommunication device for hearing- and speech-impaired... of General Routine Uses inadvertently reported repeated information that HUD proposes to exclude from...

76 FR 4653 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-26

... Activities; Submission to OMB for Review and Approval; Comment Request; Recordkeeping Requirements for... Insecticide, Fungicide, and Rodenticide Act (FIFRA); EPA ICR No. 0143.11, OMB Control No. 2070-0028 AGENCY... Devices Under Section 8 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). ICR numbers...

78 FR 9457 - Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

... applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under title XVIII of the Act (Medicare) or a State plan under title XIX (Medicaid) or XXI of the Act (the Children's Health..., ``Conflict of Interest in Medical Research, Education and Practice.'' Given these recommendations and other...

77 FR 11401 - Marine Sanitation Devices (MSDs): No Discharge Zone (NDZ) for California State Marine Waters

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-27

... Plastic Pollution Research and Control Act of 1987, and the Ocean Dumping Act, address pollution within... related legislation in 2003-2005 to limit pollution from large passenger and large oceangoing vessels. In...; (3) to further regulate landside sources of pollution; (4) to improve inspection and testing...

Social Network Aided Plagiarism Detection

ERIC Educational Resources Information Center

Zrnec, Aljaž; Lavbic, Dejan

2017-01-01

The prevalence of different kinds of electronic devices and the volume of content on the Web have increased the amount of plagiarism, which is considered an unethical act. If we want to be efficient in the detection and prevention of these acts, we have to improve today's methods of discovering plagiarism. The paper presents a research study where…

21 CFR 821.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Definitions. 821.3 Section 821.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... terms apply to this part: (a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq...

21 CFR 821.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Definitions. 821.3 Section 821.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... terms apply to this part: (a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq...

21 CFR 821.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Definitions. 821.3 Section 821.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... terms apply to this part: (a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq...

Symposium: A Pentadic Analysis of Richard Nixon and Watergate.

ERIC Educational Resources Information Center

Andersen, Kenneth E., Ed.

1977-01-01

Kenneth Burke's Dramatistic Pentad is an analytical device intended to be used by critics to discover the roots of motivation for particular acts. The five elements of the pentad are the scene, act, agent, agency, and purpose. Using the Burkean Pentad, this symposium presents the following five analyses of Watergate: "Scenic Responsibility:…

Magnetic Membrane System

DOEpatents

McElfresh, Michael W.; ; Lucas, Matthew S.

2004-12-30

The present invention provides a membrane with magnetic particles. In one embodiment the membrane is created by mixing particles in a non-magnetic base. The membrane may act as an actuator, a sensor, a pump, a valve, or other device. A magnet is operatively connected to the membrane. The magnet acts on and changes the shape of the membrane.

Highly stable piezo-immunoglobulin-biosensing of a SiO2/ZnO nanogenerator as a self-powered/active biosensor arising from the field effect influenced piezoelectric screening effect.

PubMed

Zhao, Yayu; Fu, Yongming; Wang, Penglei; Xing, Lili; Xue, Xinyu

2015-02-07

Highly stable piezo-immunoglobulin-biosensing has been realized from a SiO2/ZnO nanowire (NW) nanogenerator (NG) as a self-powered/active biosensor. The piezoelectric output generated by the SiO2/ZnO NW NG can act not only as a power source for driving the device, but also as a sensing signal for detecting immunoglobulin G (IgG). The stability of the device is very high, and the relative standard deviation (RSD) ranges from 1.20% to 4.20%. The limit of detection (LOD) of IgG on the device can reach 5.7 ng mL(-1). The response of the device is in a linear relationship with IgG concentration. The biosensing performance of SiO2/ZnO NWs is much higher than that of bare ZnO NWs. A SiO2 layer uniformly coated on the surface of the ZnO NW acts as the gate insulation layer, which increases mechanical robustness and protects it from the electrical leakages and short circuits. The IgG biomolecules modified on the surface of the SiO2/ZnO NW act as a gate potential, and the field effect can influence the surface electron density of ZnO NWs, which varies the screening effect of free-carriers on the piezoelectric output. The present results demonstrate a feasible approach for a highly stable self-powered/active biosensor.

Simultaneous RGB lasing from a single-chip polymer device.

PubMed

Yamashita, Kenichi; Takeuchi, Nobutaka; Oe, Kunishige; Yanagi, Hisao

2010-07-15

This Letter describes the fabrication and operation of a single-chip white-laser device. The laser device has a multilayered structure consisting of three laser layers. Each laser layer comprises polymer claddings and a waveguide core doped with organic dye. In each laser layer, grating corrugations were fabricated by UV-nanoimprint lithography that act as distributed-feedback cavity structures. Under optical pumping, lasing output with red, green, and blue colors was simultaneously obtained from the sample edge.

Fabryq: Using Phones as Smart Proxies to Control Wearable Devices from the Web

DTIC Science & Technology

2014-06-12

energy efficient, embedded low power device with a short range radio; 2) a user’s mobile phone, which shows a user interface but also acts as a router...ically relays information to a companion application running on the user’s mobile phone (or PC), which in turn communi- cates with servers that the...skills in several diverse fields. Thus, experimentation in deploy- able, mobile wearable devices is largely reserved to experts, and implementation cycles

Multifunctional graphene optoelectronic devices capable of detecting and storing photonic signals.

PubMed

Jang, Sukjae; Hwang, Euyheon; Lee, Youngbin; Lee, Seungwoo; Cho, Jeong Ho

2015-04-08

The advantages of graphene photodetectors were utilized to design a new multifunctional graphene optoelectronic device. Organic semiconductors, gold nanoparticles (AuNPs), and graphene were combined to fabricate a photodetecting device with a nonvolatile memory function for storing photonic signals. A pentacene organic semiconductor acted as a light absorption layer in the device and provided a high hole photocurrent to the graphene channel. The AuNPs, positioned between the tunneling and blocking dielectric layers, acted as both a charge trap layer and a plasmonic light scatterer, which enable storing of the information about the incident light. The proposed pentacene-graphene-AuNP hybrid photodetector not only performed well as a photodetector in the visible light range, it also was able to store the photonic signal in the form of persistent current. The good photodetection performance resulted from the plasmonics-enabled enhancement of the optical absorption and from the photogating mechanisms in the pentacene. The device provided a photoresponse that depended on the wavelength of incident light; therefore, the signal information (both the wavelength and intensity) of the incident light was effectively committed to memory. The simple process of applying a negative pulse gate voltage could then erase the programmed information. The proposed photodetector with the capacity to store a photonic signal in memory represents a significant step toward the use of graphene in optoelectronic devices.

Giant electron-hole transport asymmetry in ultra-short quantum transistors

PubMed Central

McRae, A. C.; Tayari, V.; Porter, J. M.; Champagne, A. R.

2017-01-01

Making use of bipolar transport in single-wall carbon nanotube quantum transistors would permit a single device to operate as both a quantum dot and a ballistic conductor or as two quantum dots with different charging energies. Here we report ultra-clean 10 to 100 nm scale suspended nanotube transistors with a large electron-hole transport asymmetry. The devices consist of naked nanotube channels contacted with sections of tube under annealed gold. The annealed gold acts as an n-doping top gate, allowing coherent quantum transport, and can create nanometre-sharp barriers. These tunnel barriers define a single quantum dot whose charging energies to add an electron or a hole are vastly different (e−h charging energy asymmetry). We parameterize the e−h transport asymmetry by the ratio of the hole and electron charging energies ηe−h. This asymmetry is maximized for short channels and small band gap tubes. In a small band gap device, we demonstrate the fabrication of a dual functionality quantum device acting as a quantum dot for holes and a much longer quantum bus for electrons. In a 14 nm-long channel, ηe−h reaches up to 2.6 for a device with a band gap of 270 meV. The charging energies in this device exceed 100 meV. PMID:28561024

Rapid detection of Cu(2+) by a paper-based microfluidic device coated with bovine serum albumin (BSA)-Au nanoclusters.

PubMed

Fang, Xueen; Zhao, Qianqian; Cao, Hongmei; Liu, Juan; Guan, Ming; Kong, Jilie

2015-11-21

In this work, bovine serum albumin (BSA)-Au nanoclusters were used to coat a paper-based microfluidic device. This device acted as a Cu(2+) biosensor that showed fluorescence quenching on detection of copper ions. The detection limit of this sensor could be adjusted by altering the water absorbing capacity of the device. Qualitative and semi-quantitative results could be obtained visually without the aid of any advanced instruments. This sensor could test Cu(2+) rapidly with high specificity and sensitivity, which would be useful for point-of-care testing (POCT).

Conductance valve and pressure-to-conductance transducer method and apparatus

DOEpatents

Schoeniger, Joseph S.; Cummings, Eric B.; Brennan, James S.

2005-01-18

A device for interrupting or throttling undesired ionic transport through a fluid network is disclosed. The device acts as a fluid valve by reversibly generating a fixed "bubble" in the conducting solvent solution carried by the network. The device comprises a porous hydrophobic structure filling a portion of a connecting channel within the network and optionally incorporates flow restrictor elements at either end of the porous structure that function as pressure isolation barriers, and a fluid reservoir connected to the region of the channel containing the porous structure. Also included is a pressure pump connected to the fluid reservoir. The device operates by causing the pump to vary the hydraulic pressure to a quantity of solvent solution held within the reservoir and porous structure. At high pressures, most or all of the pores of the structure are filled with conducting liquid so the ionic conductance is high. At lower pressures, only a fraction of the pores are filled with liquid, so ionic conductivity is lower. Below a threshold pressure, the porous structure contains only vapor, so there is no liquid conduction path. The device therefore effectively throttles ionic transport through the porous structure and acts as a "conductance valve" or "pressure-to-conductance" transducer within the network.

21 CFR 1.20 - Presence of mandatory label information.

Code of Federal Regulations, 2011 CFR

2011-04-01

... information. The term package means any container or wrapping in which any food, drug, device, or cosmetic is...) of the Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 387(13)) defining “package,” the term package means any container or wrapping in which any food, drug, device, or cosmetic is enclosed...

21 CFR 866.6050 - Ovarian adnexal mass assessment score test system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or... § 866.1(e). (c) Black box warning. Under section 520(e) of the Federal Food, Drug, and Cosmetic Act... box and must appear in all advertising, labeling, and promotional material for these devices. That...

21 CFR 866.6050 - Ovarian adnexal mass assessment score test system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or... § 866.1(e). (c) Black box warning. Under section 520(e) of the Federal Food, Drug, and Cosmetic Act... box and must appear in all advertising, labeling, and promotional material for these devices. That...

76 FR 60870 - In the Matter of Certain Electronic Devices With Communication Capabilities, Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-808] In the Matter of Certain Electronic Devices... Investigation; Institution of Investigation Pursuant to 19 U.S.C. 1337 AGENCY: U.S. International Trade.... International Trade Commission on August 16, 2011, under section 337 of the Tariff Act of 1930, as amended, 19 U...

21 CFR 821.20 - Devices subject to tracking.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... within § 821.1(a) must track that device in accordance with this part, if FDA issues a tracking order to... the criteria of section 519(e)(1) of the act and, by virtue of the order, the sponsor must track the...

21 CFR 821.20 - Devices subject to tracking.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... within § 821.1(a) must track that device in accordance with this part, if FDA issues a tracking order to... the criteria of section 519(e)(1) of the act and, by virtue of the order, the sponsor must track the...

7 CFR 61.2a - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Designation of official certificates, memoranda, marks, other identifications, and devices for purpose of the Agricultural Marketing Act. 61.2a Section 61.2a Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices)...

75 FR 29520 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-26

... section 1404(b) of the Act (``Drain Cover Standard''). In addition to the anti-entrapment devices or... system; gravity drainage system; automatic pump shut-off system or drain disablement. The Pool and Spa... the drain covers, anti-entrapment device/systems, sump or equalizer lines at the site; and report on...

9 CFR 592.5 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Designation of official certificates, memoranda, marks, other identifications, and devices for purposes of the Agricultural Marketing Act. 592.5 Section 592.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY...

9 CFR 592.5 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Designation of official certificates, memoranda, marks, other identifications, and devices for purposes of the Agricultural Marketing Act. 592.5 Section 592.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY...

9 CFR 592.5 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Designation of official certificates, memoranda, marks, other identifications, and devices for purposes of the Agricultural Marketing Act. 592.5 Section 592.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY...

21 CFR 806.30 - FDA access to records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all reasonable...

21 CFR 806.30 - FDA access to records.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all reasonable...

21 CFR 806.30 - FDA access to records.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all reasonable...

21 CFR 806.30 - FDA access to records.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all reasonable...

21 CFR 806.30 - FDA access to records.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all reasonable...

Soft ionization device with characterization systems and methods of manufacture

NASA Technical Reports Server (NTRS)

Hartley, Frank T. (Inventor)

2004-01-01

Various configurations of characterization systems such as ion mobility spectrometers and mass spectrometers are disclosed that are coupled to an ionization device. The ionization device is formed of a membrane that houses electrodes therein that are located closer to one another than the mean free path of the gas being ionized. Small voltages across the electrodes generate large electric fields which act to ionize substantially all molecules passing therethrough without fracture. Methods to manufacture the mass spectrometer and ion mobility spectrometer systems are also described.

Device-tax repeal surfaces as key in budget stalemate. White House says it's unwilling to compromise until shutdown ends.

PubMed

Lee, Jaimy; Zigmond, Jessica

2013-10-14

As lawmakers in D.C. continue to wrangle over how to solve the government shutdown and debt ceiling impasse, the Affordable Care Act's medical device tax is emerging as a likely bargaining chip. But many wonder how the tax's $29.1 billion in funding for coverage expansion will be replaced. Minnesota GOP Rep. Erik Paulsen, says he's encouraged that there is a strong chance the device tax could be overturned.

Devices and methods of operation thereof for providing stable flow for centrifugal compressors

NASA Technical Reports Server (NTRS)

Skoch, Gary J. (Inventor); Stevens, Mark A. (Inventor); Jett, Thomas A. (Inventor)

2008-01-01

Centrifugal compressor flow stabilizing devices and methods of operation thereof are disclosed that act upon the flow field discharging from the impeller of a centrifugal compressor and modify the flow field ahead of the diffuser vanes such that flow conditions contributing to rotating stall and surge are reduced or even eliminated. In some embodiments, shaped rods and methods of operation thereof are disclosed, whereas in other embodiments reverse-tangent air injection devices and methods are disclosed.

Quantum Device Applications of Mesoscopic Superconductivity

NASA Astrophysics Data System (ADS)

Hakonen, P. J.

2006-08-01

A brief account is given on the possibilities of mesoscopic superconductivity in low-noise amplifier and detector applications. In particular, three devices will be described: 1) Bloch oscillating transistor (BOT), 2) Inductively-read superconducting Cooper pair transistor (L-SET), and 3) Quantum capacitive phase detector (C-SET). The BOT is a low-noise current amplifier while the L-SET and C-SET act as ultra-sensitive charge and phase detectors, respectively. The basic operating principles and the main characteristics of these devices will be reviewed and discussed.

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).

Establishment of effective control factors to achieve federal enforcement consistency with the Highway Beautification Act : a final report submitted to Florida Department of Transportation, Right of Way Division.

DOT National Transportation Integrated Search

2017-10-01

The Highway Beautification Act, which was enforced in 1965, aims to establish an efficient outdoor advertising control (OAC) program for erection and maintenance of the outdoor advertising signs, displays and devices, which are located in a close pro...

77 FR 34388 - Determination of Regulatory Review Period for Purposes of Patent Extension; CYSVIEW (Previously...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-11

... Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L... patented item (human drug product, animal drug product, medical device, food additive, or color additive... drug products, the testing phase begins when the exemption to permit the clinical investigations of the...

75 FR 17414 - Determination of Regulatory Review Period for Purposes of Patent Extension; TOVIAZ

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

... Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act... as the patented item (human drug product, animal drug product, medical device, food additive, or... approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical...

75 FR 18213 - Determination of Regulatory Review Period for Purposes of Patent Extension; MOZOBIL

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

... Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act... as the patented item (human drug product, animal drug product, medical device, food additive, or... approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical...

75 FR 19406 - Determination of Regulatory Review Period for Purposes of Patent Extension; AFINITOR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-14

... Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act... as the patented item (human drug product, animal drug product, medical device, food additive, or... approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical...

76 FR 36929 - Determination of Regulatory Review Period for Purposes of Patent Extension; DEXILANT

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-23

... Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L... patented item (human drug product, animal drug product, medical device, food additive, or color additive... drug products, the testing phase begins when the exemption to permit the clinical investigations of the...

75 FR 17415 - Determination of Regulatory Review Period for Purposes of Patent Extension; FANAPT

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

... Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act... as the patented item (human drug product, animal drug product, medical device, food additive, or... approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical...

Terrorist Material Support: An Overview of 18 U.S.C. 2339A and 2339B

DTIC Science & Technology

2010-07-19

child (which also is not a violent act), is an ‘act dangerous to human life.’ And it violates ... 18 U.S.C. §2339A(a), which provides that ‘whoever...United States. Giving money to Hamas, like giving a loaded gun to a child (which also is not a violent act), is an ‘act dangerous to human life.’ And...explosive or incendiary devices, or endangerment of human life by means of weapons, on an aircraft within U.S. jurisdiction) 49 U.S.C. 46506 (homicide or

Airway clearance techniques for bronchiectasis.

PubMed

Lee, Annemarie L; Burge, Angela T; Holland, Anne E

2015-11-23

People with non-cystic fibrosis bronchiectasis commonly experience chronic cough and sputum production, features that may be associated with progressive decline in clinical and functional status. Airway clearance techniques (ACTs) are often prescribed to facilitate expectoration of sputum from the lungs, but the efficacy of these techniques in a stable clinical state or during an acute exacerbation of bronchiectasis is unclear. Primary: to determine effects of ACTs on rates of acute exacerbation, incidence of hospitalisation and health-related quality of life (HRQoL) in individuals with acute and stable bronchiectasis. Secondary: to determine whether:• ACTs are safe for individuals with acute and stable bronchiectasis; and• ACTs have beneficial effects on physiology and symptoms in individuals with acute and stable bronchiectasis. We searched the Cochrane Airways Group Specialised Register of trials from inception to November 2015 and PEDro in March 2015, and we handsearched relevant journals. Randomised controlled parallel and cross-over trials that compared an ACT versus no treatment, sham ACT or directed coughing in participants with bronchiectasis. We used standard methodological procedures as expected by The Cochrane Collaboration. Seven studies involving 105 participants met the inclusion criteria of this review, six of which were cross-over in design. Six studies included adults with stable bronchiectasis; the other study examined clinically stable children with bronchiectasis. Three studies provided single treatment sessions, two lasted 15 to 21 days and two were longer-term studies. Interventions varied; some control groups received a sham intervention and others were inactive. The methodological quality of these studies was variable, with most studies failing to use concealed allocation for group assignment and with absence of blinding of participants and personnel for outcome measure assessment. Heterogeneity between studies precluded inclusion of these data in the meta-analysis; the review is therefore narrative.One study including 20 adults that compared an airway oscillatory device versus no treatment found no significant difference in the number of exacerbations at 12 weeks (low-quality evidence). Data were not available for assessment of the impact of ACTs on time to exacerbation, duration or incidence of hospitalisation or total number of hospitalised days. The same study reported clinically significant improvements in HRQoL on both disease-specific and cough-related measures. The median difference in the change in total St George's Respiratory Questionnaire (SGRQ) score over three months in this study was 7.5 units (P value = 0.005 (Wilcoxon)). Treatment consisting of high-frequency chest wall oscillation (HFCWO) or a mix of ACTs prescribed for 15 days significantly improved HRQoL when compared with no treatment (low-quality evidence). Two studies reported mean increases in sputum expectoration with airway oscillatory devices in the short term of 8.4 mL (95% confidence interval (CI) 3.4 to 13.4 mL) and in the long term of 3 mL (P value = 0.02). HFCWO improved forced expiratory volume in one second (FEV1) by 156 mL and forced vital capacity (FVC) by 229.1 mL when applied for 15 days, but other types of ACTs showed no effect on dynamic lung volumes. Two studies reported a reduction in pulmonary hyperinflation among adults with non-positive expiratory pressure (PEP) ACTs (difference in functional residual capacity (FRC) of 19%, P value < 0.05; difference in total lung capacity (TLC) of 703 mL, P value = 0.02) and with airway oscillatory devices (difference in FRC of 30%, P value < 0.05) compared with no ACTs. Low-quality evidence suggests that ACTs (HFCWO, airway oscillatory devices or a mix of ACTs) reduce symptoms of breathlessness and cough and improve ease of sputum expectoration compared with no treatment (P value < 0.05). ACTs had no effect on gas exchange, and no studies reported effects of antibiotic usage. Among studies exploring airway oscillating devices, investigators reported no adverse events. ACTs appear to be safe for individuals (adults and children) with stable bronchiectasis and may account for improvements in sputum expectoration, selected measures of lung function, symptoms and HRQoL. The role of these techniques in acute exacerbation of bronchiectasis is unknown. In view of the chronic nature of bronchiectasis, additional data are needed to establish the short-term and long-term clinical value of ACTs for patient-important outcomes and for long-term clinical parameters that impact disease progression in individuals with stable bronchiectasis, allowing further guidance on prescription of specific ACTs for people with bronchiectasis.

Charge collection and SEU mechanisms

NASA Astrophysics Data System (ADS)

Musseau, O.

1994-01-01

In the interaction of cosmic ions with microelectronic devices a dense electron-hole plasma is created along the ion track. Carriers are separated and transported by the electric field and under the action of the concentration gradient. The subsequent collection of these carriers induces a transient current at some electrical node of the device. This "ionocurrent" (single ion induced current) acts as any electrical perturbation in the device, propagating in the circuit and inducing failures. In bistable systems (registers, memories) the stored data can be upset. In clocked devices (microprocessors) the parasitic perturbation may propagate through the device to the outputs. This type of failure only effects the information, and do not degrade the functionally of the device. The purpose of this paper is to review the mechanisms of single event upset in microelectronic devices. Experimental and theoretical results are presented, and actual questions and problems are discussed. A brief introduction recalls the creation of the dense plasma of electron-hole pairs. The basic processes for charge collection in a simple np junction (drift and diffusion) are presented. The funneling-field effect is discussed and experimental results are compared to numerical simulations and semi-empirical models. Charge collection in actual microelectronic structures is then presented. Due to the parasitic elements, coupling effects are observed. Geometrical effects, in densely packed structures, results in multiple errors. Electronic couplings are due to the carriers in excess, acting as minority carriers, that trigger parasitic bipolar transistors. Single event upset of memory cells is discussed, based on numerical and experimental data. The main parameters for device characterization are presented. From the physical interpretation of charge collection mechanisms, the intrinsic sensitivity of various microelectronic technologies is determined and compared to experimental data. Scaling laws and future trends are finally discussed.

50 CFR 27.72 - Audio equipment.

Code of Federal Regulations, 2014 CFR

2014-10-01

... NATIONAL WILDLIFE REFUGE SYSTEM PROHIBITED ACTS Disturbing Violations: Filming, Photography, and Light and..., recording and playback devices, loudspeakers, television sets, public address systems and musical...

50 CFR 27.72 - Audio equipment.

Code of Federal Regulations, 2013 CFR

2013-10-01

... NATIONAL WILDLIFE REFUGE SYSTEM PROHIBITED ACTS Disturbing Violations: Filming, Photography, and Light and..., recording and playback devices, loudspeakers, television sets, public address systems and musical...

Rapid Detection of Microbial Contamination Using a Microfluidic Device.

PubMed

Al-Adhami, Mustafa; Tilahun, Dagmawi; Rao, Govind; Gurramkonda, Chandrasekhar; Kostov, Yordan

2017-01-01

A portable kinetics fluorometer is developed to detect viable cells which may be contaminating various samples. The portable device acts as a single-excitation, single-emission photometer that continuously measures fluorescence intensity of an indicator dye and plots it. The slope of the plot depends on the number of colony forming units per milliliter. The device uses resazurin as the indicator dye. Viable cells reduce resazurin to resorufin, which is more fluorescent. Photodiode is used to detect fluorescence change. The photodiode generated current proportional to the intensity of the light that reached it, and an op-amp is used in a transimpedance differential configuration to ensure amplification of the photodiode's signal. A microfluidic chip is designed specifically for the device. It acts as a fully enclosed cuvette, which enhances the resazurin reduction rate. In tests, the E. coli-containing media are injected into the microfluidic chip and the device is able to detect the presence of E. coli in LB media based on the fluorescence change that occurred in the indicator dye. The device provides fast, accurate, and inexpensive means to optical detection of the presence of viable cells and could be used in the field in place of more complex methods, i.e., loop-meditated isothermal amplification of DNA (LAMP) to detect bacteria in pharmaceutical samples (Jimenez et al., J Microbiol Methods 41(3):259-265, 2000) or measuring the intrinsic fluorescence of the bacterial or yeast chromophores (Estes et al., Biosens Bioelectron 18(5):511-519, 2003).

A Tunable, Biodegradable, Thin-Film Polymer Device as a Long-Acting Implant Delivering Tenofovir Alafenamide Fumarate for HIV Pre-exposure Prophylaxis

PubMed Central

Schlesinger, Erica; Johengen, Daniel; Luecke, Ellen; Rothrock, Ginger; McGowan, Ian; van der Straten, Ariane; Desai, Tejal

2016-01-01

Purpose The effectiveness of Tenofovir based HIV pre-exposure prophylaxis (PrEP) is proven, but hinges on correct and consistent use. User compliance and therapeutic effectiveness can be improved by long acting drug delivery systems. Here we describe a thin-film polymer device (TFPD) as a biodegradable subcutaneous implant for PrEP. Methods A thin-film polycaprolactone (PCL) membrane controls drug release from a reservoir. To achieve membrane controlled release, TAF requires a formulation excipient such as PEG300 to increase the dissolution rate and reservoir solubility. Short-term In vitro release studies are used to develop an empirical design model, which is applied to the production of in vitro prototype devices demonstrating up to 90-days of linear release and TAF chemical stability. Results The size and shape of the TFPD are tunable, achieving release rates ranging from 0.5–4.4 mg/day in devices no larger than a contraceptive implant. Based on published data for oral TAF, subcutaneous constant-rate release for HIV PrEP is estimated at < 2.8mg/day. Prototype devices demonstrated linear release at 1.2mg/day for up to 90 days and at 2.2mg/day for up to 60 days. Conclusions We present a biodegradable TFPD for subcutaneous delivery of TAF for HIV PrEP. The size, shape and release rate of the device are tunable over a > 8-fold range. PMID:26975357

An Acoustic Charge Transport Imager for High Definition Television Applications: Low-Voltage SAW Amplifiers on Multilayer GaAs/ZnO Substrates

NASA Technical Reports Server (NTRS)

Hunt, W. D.; Brennan, K. F.; Summers, C. J.; Cameron, Thomas P.

1996-01-01

This thesis addresses the acoustoelectric issues concerning the amplification of surface acoustic waves (SAWs) and the reflection of SAWs from slanted reflector gratings on GaAs, with application to a novel acoustic charge transport (ACT) device architecture. First a simple model of the SAWAMP was developed, which was subsequently used to define the epitaxially grown material structure necessary to provide simultaneously high resistance and high electron mobility. In addition, a segmented SAWAMP structure was explored with line widths on the order of an acoustic wavelength. This resulted in the demonstration of SAWAMPS with an order of magnitude less voltage and power requirements than previously reported devices. A two-dimensional model was developed to explain the performance of devices with charge confinement layers less then 0.5 mm, which was experimentally verified. This model was extended to predict a greatly increased gain from the addition of a ZnO overlay. These overlays were experimentally attempted, but no working devices were reported due to process incompatibilities. In addition to the SAWAMP research, the reflection of SAWs from slanted gratings on GaAs was also studied and experimentally determined reflection coefficients for both 45 deg grooves and Al stripes on GaAs have been reported for the first time. The SAWAMp and reflector gratings were combined to investigate the integrated ring oscillator for application to the proposed ACT device and design parameters for this device have been provided.

21 CFR 2.125 - Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Use of ozone-depleting substances in foods, drugs... Specific Products Subject to the Federal Food, Drug, and Cosmetic Act § 2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics. (a) As used in this section, ozone-depleting substance...

21 CFR 2.125 - Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Use of ozone-depleting substances in foods, drugs... Specific Products Subject to the Federal Food, Drug, and Cosmetic Act § 2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics. (a) As used in this section, ozone-depleting substance...

21 CFR 2.125 - Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Use of ozone-depleting substances in foods, drugs... Specific Products Subject to the Federal Food, Drug, and Cosmetic Act § 2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics. (a) As used in this section, ozone-depleting substance...

21 CFR 2.125 - Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Use of ozone-depleting substances in foods, drugs... Specific Products Subject to the Federal Food, Drug, and Cosmetic Act § 2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics. (a) As used in this section, ozone-depleting substance...

Digital Course Materials: A Case Study of the Apple iPad in the Academic Environment

ERIC Educational Resources Information Center

Cameron, Andrea H.; Bush, Michael H.

2011-01-01

The newness of the iPad device creates a phenomenon unique and unstudied in the academic environment. By merging the innovations of electronic text, e-reader, and multi-modal functionality, the iPad tablet device can act as an e-reader providing digital course materials as well as a range of other supplementary academic applications. This…

78 FR 55014 - Machine Guns, Destructive Devices and Certain Other Firearms; Background Checks for Responsible...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-09

... No. ATF 41P; AG Order No. 3398-2013] RIN 1140-AA43 Machine Guns, Destructive Devices and Certain..., exportation, transfer, taxing, identification, registration of, and the dealing in, machine guns, destructive... section 922(g)(5)(B) of the Gun Control Act, 18 U.S.C. 922(g)(5)(B), it generally is unlawful for any...

21 CFR 814.46 - Withdrawal of approval of a PMA.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.46 Withdrawal of approval of a PMA. (a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that: (1) Any of the grounds under section 515(e)(1) (A)-(G) of the act...

21 CFR 814.46 - Withdrawal of approval of a PMA.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.46 Withdrawal of approval of a PMA. (a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that: (1) Any of the grounds under section 515(e)(1) (A)-(G) of the act...

21 CFR 830.210 - Eligibility for use of FDA as an issuing agency.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Eligibility for use of FDA as an issuing agency... SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA as an Issuing Agency § 830.210 Eligibility for use of FDA as an issuing agency. When FDA acts as an issuing agency, any labeler will be...

21 CFR 814.46 - Withdrawal of approval of a PMA.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.46 Withdrawal of approval of a PMA. (a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that: (1) Any of the grounds under section 515(e)(1) (A)-(G) of the act...

75 FR 60761 - Medical Device User Fee and Modernization Act; Notice to Public of Web site Location of Fiscal...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-01

... list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for... annually posting a list of guidance documents that CDRH is considering for development and providing... CDRH is intending to work over the next Fiscal Year (FY). We note that the agency is not required to...

77 FR 70449 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

... of guidance documents that the Center for Devices and Radiological Health (CDRH) is intending to... notice announces the Web site location of the two lists of guidance documents which CDRH is intending to... list. FDA and CDRH priorities are subject to change at any time. Topics on this and past guidance...

76 FR 61367 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-04

... the Agency will post a list of guidance documents the Center for Devices and Radiological Health (CDRH... guidance documents that CDRH is considering for development and providing stakeholders an opportunity to.... This notice announces the Web site location of the list of guidances on which CDRH is intending to work...

16 CFR 503.5 - Interpretation of the definition of “consumer commodity” as contained in section 10(a) of the...

Code of Federal Regulations, 2010 CFR

2010-01-01

... the term consumer commodity in four classifications. These are: (1) Any food, drug, device, or... Act as to any food, drug, device, or cosmetic has been delegated to the Secretary of Health, Education... connection will regard as one criterion the extent to which the disclosures required on “consumer commodities...

Plasma jet ignition device

DOEpatents

McIlwain, Michael E.; Grant, Jonathan F.; Golenko, Zsolt; Wittstein, Alan D.

1985-01-15

An ignition device of the plasma jet type is disclosed. The device has a cylindrical cavity formed in insulating material with an electrode at one end. The other end of the cylindrical cavity is closed by a metal plate with a small orifice in the center which plate serves as a second electrode. An arc jumping between the first electrode and the orifice plate causes the formation of a highly-ionized plasma in the cavity which is ejected through the orifice into the engine cylinder area to ignite the main fuel mixture. Two improvements are disclosed to enhance the operation of the device and the length of the plasma plume. One improvement is a metal hydride ring which is inserted in the cavity next to the first electrode. During operation, the high temperature in the cavity and the highly excited nature of the plasma breaks down the metal hydride, liberating hydrogen which acts as an additional fuel to help plasma formation. A second improvement consists of a cavity insert containing a plurality of spaced, metal rings. The rings act as secondary spark gap electrodes reducing the voltage needed to maintain the initial arc in the cavity.

Patients' perspectives about why they have their contraceptive Implanon NXT device removed early.

PubMed

Flore, Meike; Chen, Xiaoshuang Lilly; Bonney, Andrew; Mullan, Judy; Dijkmans-Hadley, Bridget; Hodgkins, Adam; Evans, Gina; Frew, Haley; Lloyd, Gail

2016-10-01

Women with long-acting, reversible contraceptive devices inserted may choose to remove them prior to their planned expiry dates. The objective of this study was to explore Australian women's experiences with the etonogestrel subdermal contraceptive implant (Implanon NXT) and why they had it removed early. Semi-structured interviews were conducted with 18 women between June 2013 and January 2014. Transcriptions of the audio-taped interviews were analysed using a constant comparative analysis framework. Two core themes of participants' responses that were identified in this study were influences on choice of contraception, which included convenience and information sources; and influences on removal of contraception, which included side effects and their negative impacts on relationships and financial costs. This study highlights that women's experiences with side effects contribute to the early removal of long-acting contraceptive devices such as Implanon NXT. This study emphasises the importance of general practitioners (GPs) in providing comprehensive information about the benefits and potential side effects associated with using these implants.

Do Children Really Mean What They Say? The Forensic Implications of Preschoolers' Linguistic Referencing

ERIC Educational Resources Information Center

Battin, David B.; Ceci, Stephen J.; Lust, Barbara C.

2012-01-01

This study compared younger (M = 53 months) and older (M = 90 months) children's use of linguistic referential devices to make a positive identification. Children were shown a 4-minute video that concluded with a wrongful act. They were interviewed 24 hours later and asked to identify the perpetrator of the wrongful act with open-ended and…

77 FR 35471 - National Environmental Policy Act Implementation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-13

... designed to promote transportation safety, security, accessibility, communication or operational efficiency... surface treatments or pavement markings, small passenger shelters, railroad warning devices, train control...

Microreactor Array Device

NASA Astrophysics Data System (ADS)

Wiktor, Peter; Brunner, Al; Kahn, Peter; Qiu, Ji; Magee, Mitch; Bian, Xiaofang; Karthikeyan, Kailash; Labaer, Joshua

2015-03-01

We report a device to fill an array of small chemical reaction chambers (microreactors) with reagent and then seal them using pressurized viscous liquid acting through a flexible membrane. The device enables multiple, independent chemical reactions involving free floating intermediate molecules without interference from neighboring reactions or external environments. The device is validated by protein expressed in situ directly from DNA in a microarray of ~10,000 spots with no diffusion during three hours incubation. Using the device to probe for an autoantibody cancer biomarker in blood serum sample gave five times higher signal to background ratio compared to standard protein microarray expressed on a flat microscope slide. Physical design principles to effectively fill the array of microreactors with reagent and experimental results of alternate methods for sealing the microreactors are presented.

Funding policies and post-abortion long-acting reversible contraception: Results from a cluster randomized trial

PubMed Central

ROCCA, Corinne H; THOMPSON, Kirsten MJ; GOODMAN, Suzan; WESTHOFF, Carolyn L; HARPER, Cynthia C

2018-01-01

Background Almost half of women having an abortion in the United States have had a prior procedure, highlighting a failure to provide adequate preventive care. Provision of intrauterine devices and implants, which have high upfront costs, can be uniquely challenging in the abortion care setting. Objective We conducted a study of a clinic-wide training intervention on long-acting reversible contraception and examined the effect of the intervention and contraceptive insurance coverage and funding policies on use of long-acting contraceptives post-abortion. Study Design This sub-analysis of a cluster, randomized trial examines data from the 648 abortion patients recruited from 17 reproductive health centers across the United States. The trial followed participants aged 18-25 who did not desire pregnancy for a year. We measured the effect of the intervention, health insurance, and funding policies on contraceptive outcomes, including intrauterine device and implant counseling and selection at the abortion visit, using logistic regression with generalized estimating equations for clustering. We used survival analysis to model actual initiation of these methods over one year. Results Women obtaining abortion care at intervention sites were more likely to report intrauterine device and implant counseling (70% vs. 41%, aOR, 3.83; 95% CI, 2.37-6.19) as well as selection of these methods (36% vs. 21%, aOR, 2.11; 95% CI, 1.39-3.21). However, actual initiation of methods was similar between study arms (22/100 woman-years each, aHR, 0.88; 95% CI, 0.51-1.51). Health insurance and funding policies were important for initiation of intrauterine devices and implants. Compared to uninsured women, those with public health insurance had far higher initiation (aHR, 2.18; 95% CI, 1.31-3.62). Women at sites that provide state Medicaid enrollees abortion coverage also had higher initiation (aHR, 1.73; 95% CI, 1.04-2.88), as did those at sites with state mandates for private health insurance to cover contraception (aHR, 1.80; 95% CI, 1.06-3.07). Few of the women with private insurance used it to pay for the abortion (28%), but those who did initiated long-acting contraceptive methods at almost twice the rate as women who paid for it themselves or with donated funds (aHR private, 1.94; 95% CI, 1.10-3.43). Conclusions The clinic-wide training increased long-acting reversible contraceptive counseling and selection, but did not change initiation for abortion patients. Long-acting method use post-abortion was strongly associated with funding. Restrictions on coverage of abortion and contraceptives in abortion settings prevent initiation of desired long-acting methods. PMID:26692178

Electron-beam-induced information storage in hydrogenated amorphous silicon device

DOEpatents

Yacobi, Ben G.

1986-01-01

A method for recording and storing information in a hydrogenated amorphous silicon device, comprising: depositing hydrogenated amorphous silicon on a substrate to form a charge-collection device; and generating defects in the hydrogenated amorphous silicon device, wherein the defects act as recombination centers that reduce the lifetime of carriers, thereby reducing charge-collection efficiency; and thus in the charge-collection mode of scanning probe instruments, regions of the hydrogenated amorphous silicon device that contain the defects appear darker in comparison to regions of the device that do not contain the defects, leading to a contrast formation for pattern recognition and information storage, in the device, which darkened areas can be restored to their original charge-collection efficiency by heating the hydrogenated amorphous silicon to a temperature of about 100.degree. C. to 250.degree. C. for a sufficient period of time to provide for such restoration.

Microfluidic Cell Culture Device

NASA Technical Reports Server (NTRS)

Takayama, Shuichi (Inventor); Cabrera, Lourdes Marcella (Inventor); Heo, Yun Seok (Inventor); Smith, Gary Daniel (Inventor)

2014-01-01

Microfluidic devices for cell culturing and methods for using the same are disclosed. One device includes a substrate and membrane. The substrate includes a reservoir in fluid communication with a passage. A bio-compatible fluid may be added to the reservoir and passage. The reservoir is configured to receive and retain at least a portion of a cell mass. The membrane acts as a barrier to evaporation of the bio-compatible fluid from the passage. A cover fluid may be added to cover the bio-compatible fluid to prevent evaporation of the bio-compatible fluid.

Administration of the Radiation Control for Health and Safety Act of 1968, Public Law 90-602, April 1, 1987 (1986 annual report). Report for January-December 1986

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

This report provides a summary of the operations of the Center for Devices and Radiological Health in carrying out that responsibility for calendar year 1986. Manufactureres of electronic products are required by 21 CFR 1002.20 to report accidental radiation occurrences to the CDRH. The Center no longer maintains a Radiation Incidents Registry, since accidental radiation occurrences are reported through the Device Experience Network (DEN) and through the requirements of the Medical Device Reporting (MDR) regulations.

75 FR 39971 - In the Matter of Certain Electronic Imaging Devices; Notice of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-13

....S. International Trade Commission on May 13, 2010, under section 337 of the Tariff Act of 1930, as... States after importation of certain electronic imaging devices by reason of infringement of certain...; claims 1-14 and 16 of the '816 patent; and claims 1-7, 11-13, 16-23, 26, 30-32, 40, and 41 of the '769...

76 FR 42136 - In the Matter of Certain Motion-Sensitive Sound Effects Devices and Image Display Devices and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-18

... the U.S. International Trade Commission on June 13, 2011, under section 337 of the Tariff Act of 1930... products containing same by reason of infringement of certain claims of U.S. Patent No. 6,150,947 (``the... submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice...

Women's Awareness of Their Contraceptive Benefits Under the Patient Protection and Affordable Care Act.

PubMed

Chuang, Cynthia H; Mitchell, Julie L; Velott, Diana L; Legro, Richard S; Lehman, Erik B; Confer, Lindsay; Weisman, Carol S

2015-11-01

The Patient Protection and Affordable Care Act mandates that there be no out-of-pocket cost for Food and Drug Administration-approved contraceptive methods. Among 987 privately insured reproductive aged Pennsylvania women, fewer than 5% were aware that their insurance covered tubal sterilization, and only 11% were aware that they had full coverage for an intrauterine device. For the Affordable Care Act contraceptive coverage mandate to affect effective contraception use and reduce unintended pregnancies, public awareness of the expanded benefits is essential.

Women’s Awareness of Their Contraceptive Benefits Under the Patient Protection and Affordable Care Act

PubMed Central

Mitchell, Julie L.; Velott, Diana L.; Legro, Richard S.; Lehman, Erik B.; Confer, Lindsay; Weisman, Carol S.

2015-01-01

The Patient Protection and Affordable Care Act mandates that there be no out-of-pocket cost for Food and Drug Administration–approved contraceptive methods. Among 987 privately insured reproductive aged Pennsylvania women, fewer than 5% were aware that their insurance covered tubal sterilization, and only 11% were aware that they had full coverage for an intrauterine device. For the Affordable Care Act contraceptive coverage mandate to affect effective contraception use and reduce unintended pregnancies, public awareness of the expanded benefits is essential. PMID:26447910

Remote observatory access via the Advanced Communications Technology Satellite

NASA Technical Reports Server (NTRS)

Horan, Stephen; Anderson, Kurt; Georghiou, Georghios

1992-01-01

An investigation of the potential for using the ACTS to provide the data distribution network for a distributed set of users of an astronomical observatory has been conducted. The investigation consisted of gathering the data and interface standards for the ACTS network and the observatory instrumentation and telecommunications devices. A simulation based on COMNET was then developed to test data transport configurations for real-time suitability. The investigation showed that the ACTS network should support the real-time requirements and allow for growth in the observatory needs for data transport.

Which inhaled corticosteroid and long-acting β-agonist combination is better in patients with moderate-to-severe asthma, a dry powder inhaler or a pressurized metered-dose inhaler?

PubMed

Muraki, Masato; Gose, Kyuya; Hanada, Soichiro; Sawaguchi, Hirochiyo; Tohda, Yuji

2017-11-01

Two main types of devices are used to facilitate the administration of inhaled corticosteroid (ICS) and long-acting β-agonist (LABA) in combination, dry powder inhalers (DPIs) and pressurized metered-dose inhalers (pMDIs). There are few reports comparing the effects of the two devices, and it is unknown which should be recommended for asthma patients with given sets of characteristics. In the current study, the beneficial effects and side effects associated with DPIs and pMDIs were compared, and the question of which device should be recommended for asthma patients was investigated. A prospective, randomized, crossover, comparative study in adult outpatients with asthma was conducted using salmeterol/fluticasone propionate combination (SFC) 50 μg/250 μg, one inhalation of Adoair ® 250 Diskus ® twice daily or two inhalations of Adoair ® 125 Aerosol twice daily, for 8 weeks. Questionnaires, exhaled nitric oxide (FeNO) tests and pulmonary function tests were administered after the use of each device for 8 weeks, and the results derived from each device were compared. Sixty-eight subjects were included in the final analysis. There were no significant differences between quality-of-life scores, FeNO, spirometry test results and forced oscillation results. With regard to patient preferences, 57.4% preferred the Adoair ® Aerosol and 35.3% preferred the Adoair ® Diskus ® , as determined via the comparative evaluation questionnaire. Although DPI prescription accounts for the predominant market share of combined ICS/LABA in Japan, patients preferred a pMDI device to a DPI device. Compared to DPIs, pMDIs may be the preferential choice for patients with asthma.

77 FR 61027 - Notice of Lodging Proposed Consent Decree Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-05

... Glass Manufacturing Company, Inc., Civil Action No. 1:12-cv-06115-RBK-JS. The action involves alleged violations of the Clean Air Act, 42 U.S.C. 7401, et seq., and N.J.A.C. 7:27-22.1, et seq., at Durand Glass... control devices on the three glass furnaces at the facility. The publication of this notice opens a period...

Using Physical and Computer Simulations of Collective Behaviour as an Introduction to Modelling Concepts for Applied Biologists

ERIC Educational Resources Information Center

Rands, Sean A.

2012-01-01

Models are an important tool in science: not only do they act as a convenient device for describing a system or problem, but they also act as a conceptual tool for framing and exploring hypotheses. Models, and in particular computer simulations, are also an important education tool for training scientists, but it is difficult to teach students the…

36 CFR § 1193.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... BOARD TELECOMMUNICATIONS ACT ACCESSIBILITY GUIDELINES General § 1193.3 Definitions. Terms used in this... standard telephone network. TTYs can include, for example, devices known as TDDs (telecommunication display...

Modern Pacemaker and Implantable Cardioverter/Defibrillator Systems Can Be Magnetic Resonance Imaging Safe

PubMed Central

Roguin, Ariel; Zviman, Menekhem M.; Meininger, Glenn R.; Rodrigues, E. Rene; Dickfeld, Timm M.; Bluemke, David A.; Lardo, Albert; Berger, Ronald D.; Calkins, Hugh; Halperin, Henry R.

2011-01-01

Background MRI has unparalleled soft-tissue imaging capabilities. The presence of devices such as pacemakers and implantable cardioverter/defibrillators (ICDs), however, is historically considered a contraindication to MRI. These devices are now smaller, with less magnetic material and improved electromagnetic interference protection. Our aim was to determine whether these modern systems can be used in an MR environment. Methods and Results We tested in vitro and in vivo lead heating, device function, force acting on the device, and image distortion at 1.5 T. Clinical MR protocols and in vivo measurements yielded temperature changes <0.5°C. Older (manufactured before 2000) ICDs were damaged by the MR scans. Newer ICD systems and most pacemakers, however, were not. The maximal force acting on newer devices was <100 g. Modern (manufactured after 2000) ICD systems were implanted in dogs (n=18), and after 4 weeks, 3- to 4-hour MR scans were performed (n=15). No device dysfunction occurred. The images were of high quality with distortion dependent on the scan sequence and plane. Pacing threshold and intracardiac electrogram amplitude were unchanged over the 8 weeks, except in 1 animal that, after MRI, had a transient (<12 hours) capture failure. Pathological data of the scanned animals revealed very limited necrosis or fibrosis at the tip of the lead area, which was not different from controls (n=3) not subjected to MRI. Conclusions These data suggest that certain modern pacemaker and ICD systems may indeed be MRI safe. This may have major clinical implications for current imaging practices. PMID:15277324

Impact of multiple-dose versus single-dose inhaler devices on COPD patients’ persistence with long-acting β2-agonists: a dispensing database analysis

PubMed Central

van Boven, Job FM; van Raaij, Joost J; van der Galiën, Ruben; Postma, Maarten J; van der Molen, Thys; Dekhuijzen, PN Richard; Vegter, Stefan

2014-01-01

Background: With a growing availability of different devices and types of medication, additional evidence is required to assist clinicians in prescribing the optimal medication in relation to chronic obstructive pulmonary disease (COPD) patients’ persistence with long-acting β2-agonists (LABAs). Aims: To assess the impact of the type of inhaler device (multiple-dose versus single-dose inhalers) on 1-year persistence and switching patterns with LABAs. Methods: A retrospective observational cohort study was performed comparing a cohort of patients initiating multiple-dose inhalers and a cohort initiating single-dose inhalers. The study population consisted of long-acting bronchodilator naive COPD patients, initiating inhalation therapy with mono-LABAs (formoterol, indacaterol or salmeterol). Analyses were performed using pharmacy dispensing data from 1994 to 2012, obtained from the IADB.nl database. Study outcomes were 1-year persistence and switching patterns. Results were adjusted for initial prescriber, initial medication, dosing regimen and relevant comorbidities. Results: In all, 575 patients initiating LABAs were included in the final study cohort. Among them, 475 (83%) initiated a multiple-dose inhaler and 100 (17%) a single-dose inhaler. Further, 269 (47%) initiated formoterol, 9 (2%) indacaterol and 297 (52%) salmeterol. There was no significant difference in persistence between users of multiple-dose or single-dose inhalers (hazard ratio: 0.98, 95% confidence interval: 0.76–1.26, P=0.99). Over 80% re-started or switched medication. Conclusions: There seems no impact of inhaler device (multiple-dose versus single-dose inhalers) on COPD patients’ persistence with LABAs. Over 80% of patients who initially seemed to discontinue LABAs, re-started their initial medication or switched inhalers or medication within 1 year. PMID:25274453

Forced Ion Migration for Chalcogenide Phase Change Memory Device

NASA Technical Reports Server (NTRS)

Campbell, Kristy A (Inventor)

2013-01-01

Non-volatile memory devices with two stacked layers of chalcogenide materials comprising the active memory device have been investigated for their potential as phase-change memories. The devices tested included GeTe/SnTe, Ge2Se3/SnTe, and Ge2Se3/SnSe stacks. All devices exhibited resistance switching behavior. The polarity of the applied voltage with respect to the SnTe or SnSe layer was critical to the memory switching properties, due to the electric field induced movement of either Sn or Te into the Ge-chalcogenide layer. One embodiment of the invention is a device comprising a stack of chalcogenide-containing layers which exhibit phase-change switching only after a reverse polarity voltage potential is applied across the stack causing ion movement into an adjacent layer and thus "activating" the device to act as a phase-change random access memory device or a reconfigurable electronics device when the applied voltage potential is returned to the normal polarity. Another embodiment of the invention is a device that is capable of exhibiting more than two data states.

Forced ion migration for chalcogenide phase change memory device

NASA Technical Reports Server (NTRS)

Campbell, Kristy A. (Inventor)

2011-01-01

Non-volatile memory devices with two stacked layers of chalcogenide materials comprising the active memory device have been investigated for their potential as phase change memories. The devices tested included GeTe/SnTe, Ge.sub.2Se.sub.3/SnTe, and Ge.sub.2Se.sub.3/SnSe stacks. All devices exhibited resistance switching behavior. The polarity of the applied voltage with respect to the SnTe or SnSe layer was critical to the memory switching properties, due to the electric field induced movement of either Sn or Te into the Ge-chalcogenide layer. One embodiment of the invention is a device comprising a stack of chalcogenide-containing layers which exhibit phase change switching only after a reverse polarity voltage potential is applied across the stack causing ion movement into an adjacent layer and thus "activating" the device to act as a phase change random access memory device or a reconfigurable electronics device when the applied voltage potential is returned to the normal polarity. Another embodiment of the invention is a device that is capable of exhibiting more that two data states.

Forced ion migration for chalcogenide phase change memory device

NASA Technical Reports Server (NTRS)

Campbell, Kristy A. (Inventor)

2012-01-01

Non-volatile memory devices with two stacked layers of chalcogenide materials comprising the active memory device have been investigated for their potential as phase-change memories. The devices tested included GeTe/SnTe, Ge.sub.2Se.sub.3/SnTe, and Ge.sub.2Se.sub.3/SnSe stacks. All devices exhibited resistance switching behavior. The polarity of the applied voltage with respect to the SnTe or SnSe layer was critical to the memory switching properties, due to the electric field induced movement of either Sn or Te into the Ge-chalcogenide layer. One embodiment of the invention is a device comprising a stack of chalcogenide-containing layers which exhibit phase-change switching only after a reverse polarity voltage potential is applied across the stack causing ion movement into an adjacent layer and thus "activating" the device to act as a phase-change random access memory device or a reconfigurable electronics device when the applied voltage potential is returned to the normal polarity. Another embodiment of the invention is a device that is capable of exhibiting more than two data states.

Epitaxial CoSi2 on MOS devices

DOEpatents

Lim, Chong Wee; Shin, Chan Soo; Petrov, Ivan Georgiev; Greene, Joseph E.

2005-01-25

An Si.sub.x N.sub.y or SiO.sub.x N.sub.y liner is formed on a MOS device. Cobalt is then deposited and reacts to form an epitaxial CoSi.sub.2 layer underneath the liner. The CoSi.sub.2 layer may be formed through a solid phase epitaxy or reactive deposition epitaxy salicide process. In addition to high quality epitaxial CoSi.sub.2 layers, the liner formed during the invention can protect device portions during etching processes used to form device contacts. The liner can act as an etch stop layer to prevent excessive removal of the shallow trench isolation, and protect against excessive loss of the CoSi.sub.2 layer.

Accuracy of physical activity monitors in pregnant women.

PubMed

Connolly, Christopher P; Coe, Dawn P; Kendrick, Jo M; Bassett, David R; Thompson, Dixie L

2011-06-01

To determine the step count accuracy of three pedometers and one accelerometer in pregnant women during treadmill walking. Participants were 30 women in the second or third trimester (20-34 wk) who were screened for pregnancy-related risk factors. Each participant was fitted with a belt containing three physical activity monitors: Yamax Digiwalker SW-200 (DW), New Lifestyles NL 2000 (NL), and GT3X ActiGraph accelerometer (ACT). The Omron HJ-720ITC (HJ) was placed in the pants' front pocket. Participants walked at 54, 67, 80, and 94 m · min for 2 min each. Actual steps were determined by an investigator using a hand-tally counter. The mean percent of steps recorded was calculated for each device at each speed and compared. Pearson correlations were used to determine the effect of body mass index and tilt angle on pedometer accuracy. There was a significant interaction between speed and device (F9,20 = 7.574, P < 0.001). Across all speeds, the NL and HJ had the lowest error. The ACT and DW underestimated the actual steps taken, particularly at the slower walking speeds. At 54 m · min, the ACT averaged 77.5% of steps and the DW averaged 56.9% of steps. Significant differences in the mean percent of steps recorded were found between devices at all speeds. Body mass index was only significantly correlated with percent of steps recorded by the NL, and there were no significant correlations between steps recorded and tilt angle. In pregnant women, the ACT and DW had more error than the NL and HJ. On the basis of these results, the NL and HJ should be considered for use in further research studies and physical activity programs that focus on walking during pregnancy.

You Own Devices Act

THOMAS, 113th Congress

Rep. Farenthold, Blake [R-TX-27

2014-09-18

House - 10/28/2014 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

75 FR 856 - Sunshine Act Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-06

... Matters: (a) Lead in Electronic Devices--Final Rule; (b) Mandatory Recall Notice--Final Rule. A live... recorded message containing the latest agenda information, call (301) 504-7948. FOR MORE INFORMATION...

Microreactor Array Device

PubMed Central

Wiktor, Peter; Brunner, Al; Kahn, Peter; Qiu, Ji; Magee, Mitch; Bian, Xiaofang; Karthikeyan, Kailash; LaBaer, Joshua

2015-01-01

We report a device to fill an array of small chemical reaction chambers (microreactors) with reagent and then seal them using pressurized viscous liquid acting through a flexible membrane. The device enables multiple, independent chemical reactions involving free floating intermediate molecules without interference from neighboring reactions or external environments. The device is validated by protein expressed in situ directly from DNA in a microarray of ~10,000 spots with no diffusion during three hours incubation. Using the device to probe for an autoantibody cancer biomarker in blood serum sample gave five times higher signal to background ratio compared to standard protein microarray expressed on a flat microscope slide. Physical design principles to effectively fill the array of microreactors with reagent and experimental results of alternate methods for sealing the microreactors are presented. PMID:25736721

Tapered rib fiber coupler for semiconductor optical devices

DOEpatents

Vawter, Gregory A.; Smith, Robert Edward

2001-01-01

A monolithic tapered rib waveguide for transformation of the spot size of light between a semiconductor optical device and an optical fiber or from the fiber into the optical device. The tapered rib waveguide is integrated into the guiding rib atop a cutoff mesa type semiconductor device such as an expanded mode optical modulator or and expanded mode laser. The tapered rib acts to force the guided light down into the mesa structure of the semiconductor optical device instead of being bound to the interface between the bottom of the guiding rib and the top of the cutoff mesa. The single mode light leaving or entering the output face of the mesa structure then can couple to the optical fiber at coupling losses of 1.0 dB or less.

The drug regulatory and review process in Guyana.

PubMed

Woo-Ming, R B

1993-01-01

After the old "Sale of Food and Drugs" Ordinance, Cap. 144 was repealed, the new Food and Drugs Act was enacted in 1971. This new Act has considerable flexibility and gives the Minister extensive authority to make Regulations (for carrying out the purposes and provisions of the Act). The Act controls the manufacture, importation, sale, advertising, labeling, packaging, and distribution of drug samples, and the testing of drugs. The Act also controls raw materials and finished products of drugs at the point of entry into the country, with a single agency coordinating both the inspection and analytical services. Developing countries could ensure the procurement of safe, good quality, and effective drugs and devices with the enactment of a similar Food and Drugs Act only. Rapid assessment of Drug Safety, Quality and Efficacy is done through Guyana's participation in the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce. This certification scheme is highly commendable especially to third-world countries. The Food and Drug Regulations (1977) have several unique features for drug, cosmetic and device control and they allow for a system of centralized control with limited staff to enforce the legislation. In summary, enforcement of legislative control of imported pharmaceuticals and product evaluation can be considered strong points in the drug regulatory and review process in Guyana. A cautious attitude is observed so as to ensure efficacy, safety, and quality of drugs entering the market. This Drug Regulatory and Review Process is recommended for implementation by third-world countries with outdated drug legislation.(ABSTRACT TRUNCATED AT 250 WORDS)

Referential Interactions of Turkish-Learning Children with Their Caregivers about Non-Absent Objects: Integration of Non-Verbal Devices and Prior Discourse

ERIC Educational Resources Information Center

Ates, Beyza S.; Küntay, Aylin C.

2018-01-01

This paper examines the way children younger than two use non-verbal devices (i.e., deictic gestures and communicative functional acts) and pay attention to discourse status (i.e., prior mention vs. newness) of referents in interactions with caregivers. Data based on semi-naturalistic interactions with caregivers of four children, at ages 1;00,…

In vivo polymerization and manufacturing of wires and supercapacitors in plants

PubMed Central

Stavrinidou, Eleni; Nilsson, K. Peter R.; Singh, Sandeep Kumar; Franco-Gonzalez, Juan Felipe; Volkov, Anton V.; Jonsson, Magnus P.; Grimoldi, Andrea; Elgland, Mathias; Zozoulenko, Igor V.; Berggren, Magnus

2017-01-01

Electronic plants, e-Plants, are an organic bioelectronic platform that allows electronic interfacing with plants. Recently we have demonstrated plants with augmented electronic functionality. Using the vascular system and organs of a plant, we manufactured organic electronic devices and circuits in vivo, leveraging the internal structure and physiology of the plant as the template, and an integral part of the devices. However, this electronic functionality was only achieved in localized regions, whereas new electronic materials that could be distributed to every part of the plant would provide versatility in device and circuit fabrication and create possibilities for new device concepts. Here we report the synthesis of such a conjugated oligomer that can be distributed and form longer oligomers and polymer in every part of the xylem vascular tissue of a Rosa floribunda cutting, forming long-range conducting wires. The plant’s structure acts as a physical template, whereas the plant’s biochemical response mechanism acts as the catalyst for polymerization. In addition, the oligomer can cross through the veins and enter the apoplastic space in the leaves. Finally, using the plant’s natural architecture we manufacture supercapacitors along the stem. Our results are preludes to autonomous energy systems integrated within plants and distribute interconnected sensor–actuator systems for plant control and optimization. PMID:28242683

Mobile locally operated detachable end-effector manipulator for endoscopic surgery.

PubMed

Kawai, Toshikazu; Shin, Myongyu; Nishizawa, Yuji; Horise, Yuki; Nishikawa, Atsushi; Nakamura, Tatsuo

2015-02-01

Local surgery is safer than remote surgery because emergencies can be more easily addressed. Although many locally operated surgical robots and devices have been developed, none can safely grasp organs and provide traction. A new manipulator with a detachable commercial forceps was developed that can act as a third arm for a surgeon situated in a sterile area near the patient. This mechanism can be disassembled into compact parts that enable mobile use. A mobile locally operated detachable end-effector manipulator (LODEM) was developed and tested. This device uses crank-slider and cable-rod mechanisms to achieve 5 degrees of freedom and an acting force of more than 5 N. The total mass is less than 15 kg. The positional accuracy and speed of the prototype device were evaluated while performing simulated in vivo surgery. The accuracy of the mobile LODEM was 0.4 mm, sufficient for handling organs. The manipulator could be assembled and disassembled in 8 min, making it highly mobile. The manipulator could successfully handle the target organs with the required level of dexterity during an in vivo laparoscopic surgical procedure. A mobile LODEM was designed that allows minimally invasive robotically assisted endoscopic surgery by a surgeon working near the patient. This device is highly promising for robotic surgery applications.

In vivo polymerization and manufacturing of wires and supercapacitors in plants.

PubMed

Stavrinidou, Eleni; Gabrielsson, Roger; Nilsson, K Peter R; Singh, Sandeep Kumar; Franco-Gonzalez, Juan Felipe; Volkov, Anton V; Jonsson, Magnus P; Grimoldi, Andrea; Elgland, Mathias; Zozoulenko, Igor V; Simon, Daniel T; Berggren, Magnus

2017-03-14

Electronic plants, e -Plants, are an organic bioelectronic platform that allows electronic interfacing with plants. Recently we have demonstrated plants with augmented electronic functionality. Using the vascular system and organs of a plant, we manufactured organic electronic devices and circuits in vivo, leveraging the internal structure and physiology of the plant as the template, and an integral part of the devices. However, this electronic functionality was only achieved in localized regions, whereas new electronic materials that could be distributed to every part of the plant would provide versatility in device and circuit fabrication and create possibilities for new device concepts. Here we report the synthesis of such a conjugated oligomer that can be distributed and form longer oligomers and polymer in every part of the xylem vascular tissue of a Rosa floribunda cutting, forming long-range conducting wires. The plant's structure acts as a physical template, whereas the plant's biochemical response mechanism acts as the catalyst for polymerization. In addition, the oligomer can cross through the veins and enter the apoplastic space in the leaves. Finally, using the plant's natural architecture we manufacture supercapacitors along the stem. Our results are preludes to autonomous energy systems integrated within plants and distribute interconnected sensor-actuator systems for plant control and optimization.

27 CFR 70.471 - Rulings.

Code of Federal Regulations, 2010 CFR

2010-04-01

... tobacco tax area; or (3) The taxes relating to machine guns, destructive devices, and certain other... Export Control Act of 1976; and the taxes relating to pistols, revolvers, firearms (other than pistols...

76 FR 8772 - Government in the Sunshine Act Meeting Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-15

...-TA-587 (Remand) (Certain Connecting Devices (``Quick Clamps'') for Use with Modular Compressed Air Conditioning Units, Including Filters, Regulators, and Lubricators (``FRL's'') That are Part of Larger...

SET Device Act

THOMAS, 112th Congress

Sen. Casey, Robert P., Jr. [D-PA

2012-02-02

Senate - 02/02/2012 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

48 CFR 3452.208-72 - Paperwork Reduction Act.

Code of Federal Regulations, 2011 CFR

2011-10-01

.... If the contractor will collect information requiring answers to identical questions from 10 or more people, no plan, questionnaire, interview guide, or other similar device for collecting information may...

48 CFR 3452.227-71 - Paperwork Reduction Act.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Government. If the contractor will collect information requiring answers to identical questions from 10 or more people then no plan, questionnaire, interview guide, or other similar device for collecting...

Validation of Passive Sampling Devices for Monitoring of Munitions Constituents in Underwater Environments

DTIC Science & Technology

2017-09-01

Compensation, and Liability Act (CERCLA) and U.S. Environmental Policy Act (USEPA) requirements to protect both human health /safety and...former VNTR is based on potential risks to human health and the environment identified via the CERCLA process, together with applicable or relevant and...evaluation. National Oceanic and Atmospheric Administration Data. Isla de Vieques. U.S. Department of Health and Human Services, Agency for Toxic

Health Care: Information on Coverage Choices for Servicemembers, Former Servicemembers, and Dependents

DTIC Science & Technology

2014-12-01

drugs, rehabilitative and habilitative services and devices, laboratory services, preventive services and chronic disease management , and pediatric ...the Patient Protection and Affordable Care Act (PPACA) is based on age, income, or other factors. The Centers for Medicare & Medicaid Services (CMS...Services MEC minimum essential coverage PPACA Patient Protection and Affordable Care Act VA Department of Veterans Affairs This is a work of the U.S

Hematology and pathology devices; reclassification; restricted devices; OTC test sample collection systems for drugs of abuse testing. Food and Drug Administration, HHS. Final rule.

PubMed

2000-04-07

The Food and Drug Administration (FDA) is reclassifying over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls) and exempting them from premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also designating OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act) and establishing restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is adding a conforming amendment to the existing classification regulation for specimen transport and storage containers to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.

Flexible Asymmetric Supercapacitor Based on Functionalized Reduced Graphene Oxide Aerogels with Wide Working Potential Window.

PubMed

Bora, Anindita; Mohan, Kiranjyoti; Doley, Simanta; Dolui, Swapan Kumar

2018-03-07

Flexible energy storage devices are in great demand since the advent of flexible electronics. Until now, flexible supercapacitors based on graphene analogues usually have had low operating potential windows. To this end, two dissimilar electrode materials with complementary potential ranges are employed to obtain an optimum cell voltage of 1.8 V. A low-temperature organic sol-gel method is used to prepare two different types of functionalized reduced graphene oxide aerogels (rGOA) where Ag nanorod functionalized rGOA acts as a negative electrode while polyaniline nanotube functionalized rGOA acts as a positive electrode. Both materials comprehensively exploit their unique properties to produce a device that has high energy and power densities. An assembled all-solid-state asymmetric supercapacitor gives a high energy density of 52.85 W h kg -1 and power density of 31.5 kW kg -1 with excellent cycling and temperature stability. The device also performs extraordinarily well under different bending conditions, suggesting its potential to meet the requirements for flexible electronics.

Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs.

PubMed

Le, Tran T

2017-01-01

Over 30 years ago, the United States (US) Congress passed the Orphan Drug Act (ODA) to encourage the development of products for rare diseases or conditions ("orphan products"). The Act provided incentives to sponsors for developing products with orphan designation and established a grant program to fund studies of orphan products. Since its enactment in 1983, the ODA has been credited for bringing more than 590 orphan drugs to the market, inspiring the implementation of orphan legislation globally, and enabling the creation of other programs that extend existing knowledge of the natural history of rare diseases and stimulate the development of medical devices for children and patients with rare diseases. This chapter provides a brief overview of the main features and successes of 5 of the orphan incentive programs administered by the US Food and Drug Administration (FDA): the Orphan Drug Designation Program, the Humanitarian Use Device (HUD) Designation Program, the Orphan Products Clinical Trials Grants Program, the Pediatric Device Consortia (PDC) Grant Program, and the Orphan Products Natural History Grants Program.

Committee Opinion No. 642: Increasing Access to Contraceptive Implants and Intrauterine Devices to Reduce Unintended Pregnancy.

PubMed

2015-10-01

Unintended pregnancy persists as a major public health problem in the United States. Although lowering unintended pregnancy rates requires multiple approaches, individual obstetrician-gynecologists may contribute by increasing access to contraceptive implants and intrauterine devices. Obstetrician-gynecologists should encourage consideration of implants and intrauterine devices for all appropriate candidates, including nulliparous women and adolescents. Obstetrician-gynecologists should adopt best practices for long-acting reversible contraception insertion. Obstetrician-gynecologists are encouraged to advocate for coverage and appropriate payment and reimbursement for every contraceptive method by all payers in all clinically appropriate circumstances.

Vaginal rings for delivery of HIV microbicides

PubMed Central

Malcolm, R Karl; Fetherston, Susan M; McCoy, Clare F; Boyd, Peter; Major, Ian

2012-01-01

Following the successful development of long-acting steroid-releasing vaginal ring devices for the treatment of menopausal symptoms and contraception, there is now considerable interest in applying similar devices to the controlled release of microbicides against HIV. In this review article, the vaginal ring concept is first considered within the wider context of the early advances in controlled-release technology, before describing the various types of ring device available today. The remainder of the article highlights the key developments in HIV microbicide-releasing vaginal rings, with a particular focus on the dapivirine ring that is presently in late-stage clinical testing. PMID:23204872

Vaginal rings for delivery of HIV microbicides.

PubMed

Malcolm, R Karl; Fetherston, Susan M; McCoy, Clare F; Boyd, Peter; Major, Ian

2012-01-01

Following the successful development of long-acting steroid-releasing vaginal ring devices for the treatment of menopausal symptoms and contraception, there is now considerable interest in applying similar devices to the controlled release of microbicides against HIV. In this review article, the vaginal ring concept is first considered within the wider context of the early advances in controlled-release technology, before describing the various types of ring device available today. The remainder of the article highlights the key developments in HIV microbicide-releasing vaginal rings, with a particular focus on the dapivirine ring that is presently in late-stage clinical testing.

The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

PubMed

Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

2014-04-01

The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug.

Traffic collisions between electric mobility devices (wheelchairs) and motor vehicles: Accidents, hubris, or self-destructive behavior?

PubMed

LaBan, Myron M; Nabity, Thomas S

2010-07-01

This study had its genesis in a personally observed collision between a motor vehicle and a motorized wheelchair (electric mobility device) on a busy street in the middle of the block at an unmarked crossing. To the observer, at the time, this appeared to be a suicidal act. This investigation was initiated to both delineate the number of these crashes nationally and understand this phenomena as a potentially planned act of self-destruction. An initial survey of police reports was immediately frustrated by an inability to separate motor vehicle and electric mobility device collisions from the much larger group that involved ambulatory citizens because both types were classified together as "pedestrian" accidents. Instead, the search engine NexisLexis was used to identify 107 newspaper articles each of which described a motor vehicle and electric mobility device accident. In the motor vehicle and electric mobility device collisions, men predominated women (3:1 ratio) with an average age of 56 yrs. Sixty of these accidents were fatal. Ninety-four percent involved an electric mobility device and 6% a manual wheelchair. In 50% of the cases, the motor vehicle was a truck, van, or sport utility vehicle. Fifty percent occurred at dusk or dawn or at night. The electric mobility device occupant was cited as the guilty party in 39% of the cases and the driver of the motor vehicle in 27%. Twenty percent were unwitnessed hit-and-run accidents, whereas "no fault" was found in 8% of the cases. Although many accidents do happen by chance, when an electric mobility device operator openly challenges busy traffic by attempting to traverse it in the middle of the block at an unmarked crossing, predisposing psychosocial factors must also be considered. Hubris or premeditated self-destructive behavior or both need to be explored as preeminent issues with reference to the prodromal of the "accident process."

75 FR 39502 - Privacy Act of 1974; System of Records

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-09

..., eyeglasses, hearing aids, prosthetic devices, diet/special nourishment plans, blood donor records, charges... years; patient accountability (admission/discharge) 5 years; blood donor 5 years or when no longer...

Large Capacity Ammunition Feeding Device Act

THOMAS, 113th Congress

Rep. McCarthy, Carolyn [D-NY-4

2013-01-03

House - 01/25/2013 Referred to the Subcommittee on Crime, Terrorism, Homeland Security, And Investigations. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Analysis and Tools for Improved Management of Connectionless and Connection-Oriented BLE Devices Coexistence

PubMed Central

Del Campo, Antonio; Cintioni, Lorenzo; Spinsante, Susanna; Gambi, Ennio

2017-01-01

With the introduction of low-power wireless technologies, like Bluetooth Low Energy (BLE), new applications are approaching the home automation, healthcare, fitness, automotive and consumer electronics markets. BLE devices are designed to maximize the battery life, i.e., to run for long time on a single coin-cell battery. In typical application scenarios of home automation and Ambient Assisted Living (AAL), the sensors that monitor relatively unpredictable and rare events should coexist with other sensors that continuously communicate health or environmental parameter measurements. The former usually work in connectionless mode, acting as advertisers, while the latter need a persistent connection, acting as slave nodes. The coexistence of connectionless and connection-oriented networks, that share the same central node, can be required to reduce the number of handling devices, thus keeping the network complexity low and limiting the packet’s traffic congestion. In this paper, the medium access management, operated by the central node, has been modeled, focusing on the scheduling procedure in both connectionless and connection-oriented communication. The models have been merged to provide a tool supporting the configuration design of BLE devices, during the network design phase that precedes the real implementation. The results highlight the suitability of the proposed tool: the ability to set the device parameters to allow us to keep a practical discovery latency for event-driven sensors and avoid undesired overlaps between scheduled scanning and connection phases due to bad management performed by the central node. PMID:28387724

Analysis and Tools for Improved Management of Connectionless and Connection-Oriented BLE Devices Coexistence.

PubMed

Del Campo, Antonio; Cintioni, Lorenzo; Spinsante, Susanna; Gambi, Ennio

2017-04-07

With the introduction of low-power wireless technologies, like Bluetooth Low Energy (BLE), new applications are approaching the home automation, healthcare, fitness, automotive and consumer electronics markets. BLE devices are designed to maximize the battery life, i.e., to run for long time on a single coin-cell battery. In typical application scenarios of home automation and Ambient Assisted Living (AAL), the sensors that monitor relatively unpredictable and rare events should coexist with other sensors that continuously communicate health or environmental parameter measurements. The former usually work in connectionless mode, acting as advertisers, while the latter need a persistent connection, acting as slave nodes. The coexistence of connectionless and connection-oriented networks, that share the same central node, can be required to reduce the number of handling devices, thus keeping the network complexity low and limiting the packet's traffic congestion. In this paper, the medium access management, operated by the central node, has been modeled, focusing on the scheduling procedure in both connectionless and connection-oriented communication. The models have been merged to provide a tool supporting the configuration design of BLE devices, during the network design phase that precedes the real implementation. The results highlight the suitability of the proposed tool: the ability to set the device parameters to allow us to keep a practical discovery latency for event-driven sensors and avoid undesired overlaps between scheduled scanning and connection phases due to bad management performed by the central node.

[Medical innovations in the area of conflict between certification and allowance].

PubMed

Möller, B; Stockheim, M; Kraus, T; Weber, A

2010-10-01

The medical technology industry is one of the most innovative industries in Germany. Once a medical product is developed, it will be certificated according to European harmonized guidelines and norms. The respective national regulations in Germany are stipulated in the Medical Devices Act (MPG). Part of the certification process is a clinical assessment with the aim to prove that the medical device complies with the so-called essential requirements concerning safety, performance and suitability for the intended use as defined by the manufacturer. A clinical trial may be necessary to establish compliance with these requirements. During this clinical trial the devices are being assessed in patients according to strict requirements by law. The main criticism by the funding agencies is that these trials do not sufficiently apply methods of evidence-based medicine. Thereby they are not useful for assessing the medical benefit of the devices. The manufacturers' counter-argument is that the products are bearing the CE mark, that they comply with the uniform European standards and that their quality therefore has been appropriately assessed. This discussion relates to the question about payment for the products, as according to the Fifth Social Act the funding agencies are only permitted to finance products with a scientifically proven medical benefit. The present article discusses both positions in the context of national and international legislation for the certification of medical devices and presents possible solutions. © Georg Thieme Verlag KG Stuttgart · New York.

Medical Device Patient Safety Act

THOMAS, 112th Congress

Sen. Grassley, Chuck [R-IA

2011-12-14

Senate - 12/14/2011 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Vessel Sewage Discharges

EPA Pesticide Factsheets

Vessel sewage discharges are regulated under Section 312 of the Clean Water Act, which is jointly implemented by the EPA and Coast Guard. This homepage links to information on marine sanitation devices and no discharge zones.

Medical Device Regulatory Improvement Act

THOMAS, 112th Congress

Sen. Klobuchar, Amy [D-MN

2011-10-13

Senate - 10/13/2011 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Pre-Paid Mobile Device Identification Act

THOMAS, 111th Congress

Sen. Schumer, Charles E. [D-NY

2010-05-26

Senate - 05/26/2010 Read twice and referred to the Committee on Commerce, Science, and Transportation. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Electronic Device Recycling Research and Development Act

THOMAS, 111th Congress

Sen. Klobuchar, Amy [D-MN

2009-07-06

Senate - 04/19/2010 Placed on Senate Legislative Calendar under General Orders. Calendar No. 351. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Funding policies and postabortion long-acting reversible contraception: results from a cluster randomized trial.

PubMed

Rocca, Corinne H; Thompson, Kirsten M J; Goodman, Suzan; Westhoff, Carolyn L; Harper, Cynthia C

2016-06-01

Almost one-half of women having an abortion in the United States have had a previous procedure, which highlights a failure to provide adequate preventive care. Provision of intrauterine devices and implants, which have high upfront costs, can be uniquely challenging in the abortion care setting. We conducted a study of a clinic-wide training intervention on long-acting reversible contraception and examined the effect of the intervention, insurance coverage, and funding policies on the use of long-acting contraceptives after an abortion. This subanalysis of a cluster, randomized trial examines data from the 648 patients who had undergone an abortion who were recruited from 17 reproductive health centers across the United States. The trial followed participants 18-25 years old who did not desire pregnancy for a year. We measured the effect of the intervention, health insurance, and funding policies on contraceptive outcomes, which included intrauterine device and implant counseling and selection at the abortion visit, with the use of logistic regression with generalized estimating equations for clustering. We used survival analysis to model the actual initiation of these methods over 1 year. Women who obtained abortion care at intervention sites were more likely to report intrauterine device and implant counseling (70% vs 41%; adjusted odds ratio, 3.83; 95% confidence interval, 2.37-6.19) and the selection of these methods (36% vs 21%; adjusted odds ratio, 2.11; 95% confidence interval, 1.39-3.21). However, the actual initiation of methods was similar between study arms (22/100 woman-years each; adjusted hazard ratio, 0.88; 95% confidence interval, 0.51-1.51). Health insurance and funding policies were important for the initiation of intrauterine devices and implants. Compared with uninsured women, those women with public health insurance had a far higher initiation rate (adjusted hazard ratio, 2.18; 95% confidence interval, 1.31-3.62). Women at sites that provide state Medicaid enrollees abortion coverage also had a higher initiation rate (adjusted hazard ratio, 1.73; 95% confidence interval, 1.04-2.88), as did those at sites with state mandates for private health insurance to cover contraception (adjusted hazard ratio, 1.80; 95% confidence interval, 1.06-3.07). Few of the women with private insurance used it to pay for the abortion (28%), but those who did initiated long-acting contraceptive methods at almost twice the rate as women who paid for it themselves or with donated funds (adjusted hazard ratio, 1.94; 95% confidence interval, 1.10-3.43). The clinic-wide training increased long-acting reversible contraceptive counseling and selection but did not change initiation for abortion patients. Long-acting method use after abortion was associated strongly with funding. Restrictions on the coverage of abortion and contraceptives in abortion settings prevent the initiation of desired long-acting methods. Copyright © 2015 Elsevier Inc. All rights reserved.

Validation and reliability of two activity monitors for energy expenditure assessment.

PubMed

Brazeau, Anne-Sophie; Beaudoin, Nadia; Bélisle, Virginie; Messier, Virginie; Karelis, Antony D; Rabasa-Lhoret, Rémi

2016-01-01

This study explores the reliability and validity of the SenseWear Armband (SWA) and Actical (ACT) for free-living total energy expenditure, and energy expenditure during rest and light-to-moderate exercises (walking, ergocycling). Participants wore the 2 devices during 7 days (free-living) and then participated to 3 days of testing in our laboratory. SWA and ACT estimates of total energy expenditure was compared to the doubly labeled water technique (7 days), and energy expenditure during rest (60min), treadmill (45min; intensities ∼22% to ∼41% VO2peak) and ergocycling (45min; ∼50% VO2peak) were compared to indirect calorimetry over the following 3 days. Paired T-tests and intra-class correlation coefficient (ICC) with 95% confidence interval (CI95) were computed. Twenty adults were recruited (BMI 23.1±2.3kg/m(2)). Compared to doubly labelled water, SWA overestimated energy expenditure by 94kcal/d (±319; P=0.2) and ACT underestimated by -244kcal/d (±258; P=0.001). Energy expenditure during rest (SWA 210±116, ACT 124±133kcal/d; p<0.05) and treadmill (according on intensity: SWA 54±46 to 67±38, ACT 68±25 to 84±40kcal; p<0.05) were overestimated and underestimated during ergocycling (SWA -93±65, ACT -269±111kcal; p<0.05) compared to indirect calorimetry. High ICC were observed at rest (SWA 0.994 CI95 0.987-0.997; ACT 0.998 CI95 0.996-0.999) and during ergocycling (SWA 0.941 CI95 0.873-0.975; ACT 0.854 CI95 0.687-0.939). Acceptable estimation of total energy expenditure was observed with the SWA. Both devices were reliable but not accurate for energy expenditure's estimations during rest and for specific exercises. Copyright © 2014 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Programmability of nanowire networks

NASA Astrophysics Data System (ADS)

Bellew, A. T.; Bell, A. P.; McCarthy, E. K.; Fairfield, J. A.; Boland, J. J.

2014-07-01

Electrical connectivity in networks of nanoscale junctions must be better understood if nanowire devices are to be scaled up from single wires to functional material systems. We show that the natural connectivity behaviour found in random nanowire networks presents a new paradigm for creating multi-functional, programmable materials. In devices made from networks of Ni/NiO core-shell nanowires at different length scales, we discover the emergence of distinct behavioural regimes when networks are electrically stressed. We show that a small network, with few nanowire-nanowire junctions, acts as a unipolar resistive switch, demonstrating very high ON/OFF current ratios (>105). However, large networks of nanowires distribute an applied bias across a large number of junctions, and thus respond not by switching but instead by evolving connectivity. We demonstrate that these emergent properties lead to fault-tolerant materials whose resistance may be tuned, and which are capable of adaptively reconfiguring under stress. By combining these two behavioural regimes, we demonstrate that the same nanowire network may be programmed to act both as a metallic interconnect, and a resistive switch device with high ON/OFF ratio. These results enable the fabrication of programmable, multi-functional materials from random nanowire networks.Electrical connectivity in networks of nanoscale junctions must be better understood if nanowire devices are to be scaled up from single wires to functional material systems. We show that the natural connectivity behaviour found in random nanowire networks presents a new paradigm for creating multi-functional, programmable materials. In devices made from networks of Ni/NiO core-shell nanowires at different length scales, we discover the emergence of distinct behavioural regimes when networks are electrically stressed. We show that a small network, with few nanowire-nanowire junctions, acts as a unipolar resistive switch, demonstrating very high ON/OFF current ratios (>105). However, large networks of nanowires distribute an applied bias across a large number of junctions, and thus respond not by switching but instead by evolving connectivity. We demonstrate that these emergent properties lead to fault-tolerant materials whose resistance may be tuned, and which are capable of adaptively reconfiguring under stress. By combining these two behavioural regimes, we demonstrate that the same nanowire network may be programmed to act both as a metallic interconnect, and a resistive switch device with high ON/OFF ratio. These results enable the fabrication of programmable, multi-functional materials from random nanowire networks. Electronic supplementary information (ESI) available: Nanowire statistics (length, diameter statistics, and oxide thickness) are provided. Forming curves for single junctions and networks. Passive voltage contrast image demonstrating selectivity of conductive pathways in 100 μm network. See DOI: 10.1039/c4nr02338b

Real-time dangling objects sensing: A preliminary design of mobile headset ancillary device for visual impaired.

PubMed

Lin, C H; Cheng, P H; Shen, S T

2014-01-01

Blinds and severe visual impairments can utilize tactile sticks to assist their walking. However, they cannot fully understand the dangling objects in front of their walking routes. This research proposed a mobile real-time dangling objects sensing (RDOS) prototype, which is located on the cap to sense any front barrier. This device utilized cheap ultrasonic sensor to act as another complement eye for blinds to understand the front dangling objects. Meanwhile, the RDOS device can dynamically adjust the sensor's front angle that is depended on the user's body height and promote the sensing accuracy. Meanwhile, two major required algorithms, height-angle measurement and ultrasonic sensor alignment, are proposed with this prototype. The research team also integrated the RDOS device prototype with mobile Android devices by communicating with Bluetooth to record the walking route.

Integrated fountain effect pump device for fluid management at low gravity

NASA Technical Reports Server (NTRS)

Yuan, S. W. K.; Frank, D. J.

1988-01-01

A new device for fluid management at low gravity is described. The system is basically the same as the enclosed capillary device using screens, in which the screens along the gallery channels are replaced by porous plugs which are responsible for both the fluid retention and pumping of He II; in this device, no downstream pump is needed. The plugs in contact with liquid He on both sides act as a fountain-effect pumps (FEPs), while plugs exposed to vapor on one side behave as vapor-liquid phase separators (VLPSs). The total net rate of He II transfer into the receiving tank equals the mass flow rate through the FEP plugs minus the liquid loss from the VLPS plugs. The results of the performance analysis of this integrated FEP device are presented together with its schematic diagram.

Alignment reference device

DOEpatents

Patton, Gail Y.; Torgerson, Darrel D.

1987-01-01

An alignment reference device provides a collimated laser beam that minimizes angular deviations therein. A laser beam source outputs the beam into a single mode optical fiber. The output end of the optical fiber acts as a source of radiant energy and is positioned at the focal point of a lens system where the focal point is positioned within the lens. The output beam reflects off a mirror back to the lens that produces a collimated beam.

Device for conversion of electromagnetic radiation into electrical current

DOEpatents

Blakeslee, A.E.; Mitchell, K.W.

1980-03-25

Electromagnetic energy may be converted directly into electrical energy by a device comprising a sandwich of at least two semiconductor portions, each portion having a p-n junction with a characteristic energy gap, and the portions lattice matched to one another by an intervening superlattice structure. This superlattice acts to block propagation into the next deposited portion of those dislocation defects which can form due to lattice mismatch between adjacent portions.

Device for conversion of electromagnetic radiation into electrical current

DOEpatents

Blakeslee, A. Eugene; Mitchell, Kim W.

1981-01-01

Electromagnetic energy may be converted directly into electrical energy by a device comprising a sandwich of at least two semiconductor portions, each portion having a p-n junction with a characteristic energy gap, and the portions lattice matched to one another by an intervening superlattice structure. This superlattice acts to block propagation into the next deposited portion of those dislocation defects which can form due to lattice mismatch between adjacent portions.

Emission control devices, fuel additive, and fuel composition changes.

PubMed Central

Piver, W T

1977-01-01

Emission control devices are installed to meet the exhaust standards of the Clean Air Act for carbon monoxide and hydrocarbons, and it is necessary to know, from a public health point of view, how exhaust emissions may be affected by changes in fuel additives and fuel composition. Since these topics are concerned with developing technologies, the available literature on exhaust emission characteristics and the limited information on health effects, is reviewed. PMID:71235

DOE Office of Scientific and Technical Information (OSTI.GOV)

Krempasky, J.; Flechsig, U.; Korhonen, T.

Synchronous monochromator and insertion device energy scans were implemented at the Surfaces/Interfaces:Microscopy (SIM) beamline in order to provide the users fast X-ray magnetic dichroism studies (XMCD). A simple software control scheme is proposed based on a fast monochromator run-time energy readback which quickly updates the insertion device requested energy during an on-the-fly X-ray absorption scan (XAS). In this scheme the Plain Grating Monochromator (PGM) motion control, being much slower compared with the insertion device (APPLE-II type undulator), acts as a 'master' controlling the undulator 'slave' energy position. This master-slave software implementation exploits EPICS distributed device control over computer network andmore » allows for a quasi-synchronous motion control combined with data acquisition needed for the XAS or XMCD experiment.« less

Efficient gas-liquid contact using microfluidic membrane devices with staggered herringbone mixers.

PubMed

Femmer, Tim; Eggersdorfer, Max L; Kuehne, Alexander J C; Wessling, Matthias

2015-08-07

We describe a novel membrane based gas-liquid-contacting device with increased mass transport and reduced pressure loss by combining a membrane with a staggered herringbone static mixer. Herringbone structures are imposed on the microfluidic channel geometry via soft lithography, acting as mixers which introduce secondary flows at the membrane interface. Such flows include Dean vortices and Taylor flows generating effective mixing while improving mass transport and preventing concentration polarization in microfluidic channels. Furthermore, our static herringbone mixer membranes effectively reduce pressure losses leading to devices with enhanced transfer properties for microfluidic gas-liquid contact. We investigate the red blood cell distribution to tailor our devices towards miniaturised extracorporeal membrane oxygenation and improved comfort of patients with lung insufficiencies.

A flexible nonvolatile resistive switching memory device based on ZnO film fabricated on a foldable PET substrate.

PubMed

Sun, Bai; Zhang, Xuejiao; Zhou, Guangdong; Yu, Tian; Mao, Shuangsuo; Zhu, Shouhui; Zhao, Yong; Xia, Yudong

2018-06-15

In this work, a flexible resistive switching memory device based on ZnO film was fabricated using a foldable Polyethylene terephthalate (PET) film as substrate while Ag and Ti acts top and bottom electrode. Our as-prepared device represents an outstanding nonvolatile memory behavior with good "write-read-erase-read" stability at room temperature. Finally, a physical model of Ag conductive filament is constructed to understanding the observed memory characteristics. The work provides a new way for the preparation of flexible memory devices based on ZnO films, and especially provides an experimental basis for the exploration of high-performance and portable nonvolatile resistance random memory (RRAM). Copyright © 2018 Elsevier Inc. All rights reserved.

FDA's perspectives on cardiovascular devices.

PubMed

Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

2009-06-01

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

Drug and Device Accountability Act of 2009

THOMAS, 111th Congress

Sen. Kennedy, Edward M. [D-MA

2009-04-23

Senate - 04/23/2009 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Novel Device Regulatory Relief Act of 2011

THOMAS, 112th Congress

Sen. Brown, Scott P. [R-MA

2011-12-05

Senate - 12/05/2011 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Next Generation Public Safety Device Act of 2010

THOMAS, 111th Congress

Sen. Warner, Mark R. [D-VA

2010-08-05

Senate - 08/05/2010 Read twice and referred to the Committee on Commerce, Science, and Transportation. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Inertial sensing microelectromechanical (MEM) safe-arm device

DOEpatents

Roesler, Alexander W [Tijeras, NM; Wooden, Susan M [Sandia Park, NM

2009-05-12

Microelectromechanical (MEM) safe-arm devices comprise a substrate upon which a sense mass, that can contain an energetic material, is constrained to move along a pathway defined by a track disposed on the surface of the substrate. The pathway has a first end comprising a "safe" position and a second end comprising an "armed" position, whereat the second end the sense mass can be aligned proximal to energetic materials comprising the explosive train, within an explosive component. The sense mass can be confined in the safe position by a first latch, operable to release the sense mass by an acceleration acting in a direction substantially normal to the surface of the substrate. A second acceleration, acting in a direction substantially parallel to the surface of the substrate, can cause the sense mass to traverse the pathway from the safe position to the armed position.

Theory and simulations of current drive via injection of an electron beam in the ACT-1 device

DOE Office of Scientific and Technical Information (OSTI.GOV)

Okuda, H.; Horton, R.; Ono, M.

1985-02-01

One- and two-dimensional particle simulations of beam-plasma interaction have been carried out in order to understand current drive experiments that use an electron beam injected into the ACT-1 device. Typically, the beam velocity along the magnetic field is V = 10/sup 9/ cm/sec while the thermal velocity of the background electrons is v/sub t/ = 10/sup 8//cm. The ratio of the beam density to the background density is about 10% so that a strong beam-plasma instability develops causing rapid diffusion of beam particles. For both one- and two- dimensional simulations, it is found that a significant amount of beam andmore » background electrons is accelerated considerably beyond the initial beam velocity when the beam density is more than a few percent of the background plasma density. In addition, electron distribution along the magnetic field has a smooth negative slope, f' (v/sub parallel/) < 0, for v/ sub parallel/ > 0 extending v/sub parallel/ = 1.5 V approx. 2 V, which is in sharp contrast to the predictions from quasilinear theory. An estimate of the mean-free path for beam electrons due to Coulomb collisions reveals that the beam electrons can propagate a much longer distance than is predicted from a quasilinear theory, due to the presence of a high energy tail. These simulation results agree well with the experimental observations from the ACT-1 device.« less

Finding of No Significant Impact & Tiered Environmental Assessment: Public Law 84-99 Rehabilitation Program Dry Creek Flood Risk Reduction Project Hawarden, Sioux County, Iowa

DTIC Science & Technology

2014-11-01

by the National Pollutant Discharge Elimination System (NPDES) permit (i.e., silt trapping devices) would be implemented as required to minimize...Natural Resources MBTA Migratory Bird Treaty Act NEPA National Environmental Policy Act NPDES National Pollutant Discharge Elimination System NWI...disturbance, bank disturbance, and riparian vegetation. This condition does not further restrict otherwise authorized drainage ditch maintenance activities

High-performance broadband photodetector using solution-processible PbSe-TiO(2)-graphene hybrids.

PubMed

Manga, Kiran Kumar; Wang, Junzhong; Lin, Ming; Zhang, Jie; Nesladek, Milos; Nalla, Venkatram; Ji, Wei; Loh, Kian Ping

2012-04-03

Highly sensitive, multicomponent broadband photodetector devices are made from PbSe/graphene/TiO(2). TiO(2) and PbSe nanoparticles act as light harvesting photoactive materials from the UV to IR regions of the electromagnetic spectrum, while the graphene acts as a charge collector for both photogenerated holes and electrons under an applied electric field. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

27 CFR 479.23 - Restrictive use of required information.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES.... Chapter 53, or this part or section 207 of the Gun Control Act of 1968 shall be used, directly or...

27 CFR 479.23 - Restrictive use of required information.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES.... Chapter 53, or this part or section 207 of the Gun Control Act of 1968 shall be used, directly or...

77 FR 65002 - Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-24

... specific pediatric needs, including research associated with a particular drug, biologic, or device. Please... infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric...

78 FR 29331 - Atlantic Coastal Fisheries Cooperative Management Act Provisions; Horseshoe Crabs; Application...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

... product used for the detection of endotoxins. The LAL assay is used by medical professionals, drug companies, and pharmacies to detect endotoxins in intravenous pharmaceuticals and medical devices that come...

77 FR 55457 - Atlantic Coastal Fisheries Cooperative Management Act Provisions; Horseshoe Crabs; Application...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-10

... product used for the detection of endotoxins. The LAL assay is used by medical professionals, drug companies, and pharmacies to detect endotoxins in intravenous pharmaceuticals and medical devices that come...

76 FR 31941 - Atlantic Coastal Fisheries Cooperative Management Act Provisions; Horseshoe Crabs; Application...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... endotoxins. The LAL assay is used by medical professionals, drug companies, and pharmacies to detect endotoxins in intravenous pharmaceuticals and medical devices that come into contact with human blood or...

Medical Device Safety Act of 2009

THOMAS, 111th Congress

Sen. Kennedy, Edward M. [D-MA

2009-03-05

Senate - 08/04/2009 Committee on Health, Education, Labor, and Pensions. Hearings held. Hearings printed: S.Hrg. 111-1031. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

75 FR 1382 - Notice of Public Information Collection, Comments Requested

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... information collection is contained in Sections 4(i), 303(r) and 629 of the Communications Act of 1934, as...(a)(1) prohibiting the deployment of integrated navigation devices by multichannel video programming...

77 FR 66478 - Steens Mountain Advisory Council; Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-05

... telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1(800) 877-8339... Steens Mountain Cooperative Management and Protection Act (CMPA) of 2000 (Pub. L. 106-399). [[Page 66479...

Piezoelectric transducer

NASA Technical Reports Server (NTRS)

Conragan, J.; Muller, R. S.

1970-01-01

Transducer consists of a hybrid thin film and a piezoelectric transistor that acts as a stress-sensitive device with built-in gain. It provides a stress/strain transducer that incorporates a signal amplification stage and sensor in a single package.

Proton Pumps: Mechanism of Action and Applications

NASA Technical Reports Server (NTRS)

Lanyi, Janos K.; Pohorille, Andrew; DeVincenzi, Donald L. (Technical Monitor)

2001-01-01

Recent progress in understanding molecular structures and mechanisms of action of proton pumps has paved the way to their novel applications in biotechnology. Proton pumps, in particular bacteriorhodopsin and ATP synthases, are capable of continuous, renewable conversion of light to chemical, mechanical or electrical energy, which can be used in macro- or nano-scale devices. The capability of protein systems incorporated into liposomes to generate ATP, which can be further used to drive chemical reactions, and to act as molecular motors has been already demonstrated. Other possible applications of such biochemical devices include targeted drug delivery and biocatalytic re actors. All these devices might prove superior to their inorganic alternatives.

Voltage controlled Bi-mode resistive switching effects in MnO2 based devices

NASA Astrophysics Data System (ADS)

Hu, P.; Wu, S. X.; Wang, G. L.; Li, H. W.; Li, D.; Li, S. W.

2018-01-01

In this paper, the voltage induced bi-mode resistive switching behavior of an MnO2 thin film based device was studied. The device showed prominent bipolar resistive switching behavior with good reproducibility and high endurance. In addition, complementary resistive switching characteristics can be observed by extending the voltage bias during voltage sweep operations. The electrical measurement data and fitting results indicate that the oxygen vacancies act as defects to form a conductive path, which is connective or disrupted to realize a low resistive state or a high resistive state. Changing the sweep voltage can tune the oxygen vacancies distribution, which will achieve complementary resistive switching.

Microstructures and fatigue life of SnAgCu solder joints bearing Nano-Al particles in QFP devices

NASA Astrophysics Data System (ADS)

Zhang, Liang; Fan, Xi-ying; Guo, Yong-huan; He, Cheng-wen

2014-05-01

Microstructures and fatigue life of SnAgCu and SnAgCu bearing nano-Al particles in QFP (Quad flat package) devices were investigated, respectively. Results show that the addition of nano-Al particles into SnAgCu solder can refine the microstructures of matrix microstructure. Moreover, the nano-Al particles present in the solder matrix, act as obstacles which can create a back stress, resisting the motion of dislocations. In QFP device, it is found that the addition of nano-Al particles can increase the fatigue life by 32% compared with the SnAgCu solder joints during thermal cycling loading.

Transplantation of Cadaver Tissues and Organs. Part 15. Chapter 338

DTIC Science & Technology

1984-01-09

different individuals should preferentially be nonviable and cleansed * •of cellular debris. * N moral and legal issues most often surround the...there is a minority who view such a position as immoral,that the individual expires only when all vegetative function ceases. 3 i Ii i ŕ " Donald J...Drug Adminstration in 1982 has ruled processed bone * as a "device", which qualifies under the Federal Food, Drug and Cosmetic Act, Medical Device

Gating electrical transport through DNA molecules that bridge between silicon nanogaps.

PubMed

Takagi, Shogo; Takada, Tadao; Matsuo, Naoto; Yokoyama, Shin; Nakamura, Mitsunobu; Yamana, Kazushige

2012-03-21

DNA electronic devices were prepared on silicon-based three-terminal electrodes. Both ends of DNA molecules (400 bp long, mixed sequences) were bridged via chemical bonds between the source-drain nanogap (120 nm) electrodes. S-Shaped I-V curves were obtained and the electric current can be modulated by the gate voltage. The DNA molecules act as semiconducting p-type nanowires in the three-terminal device. This journal is © The Royal Society of Chemistry 2012

Electric field-triggered metal-insulator transition resistive switching of bilayered multiphasic VOx

NASA Astrophysics Data System (ADS)

Won, Seokjae; Lee, Sang Yeon; Hwang, Jungyeon; Park, Jucheol; Seo, Hyungtak

2018-01-01

Electric field-triggered Mott transition of VO2 for next-generation memory devices with sharp and fast resistance-switching response is considered to be ideal but the formation of single-phase VO2 by common deposition techniques is very challenging. Here, VOx films with a VO2-dominant phase for a Mott transition-based metal-insulator transition (MIT) switching device were successfully fabricated by the combined process of RF magnetron sputtering of V metal and subsequent O2 annealing to form. By performing various material characterizations, including scanning transmission electron microscopy-electron energy loss spectroscopy, the film is determined to have a bilayer structure consisting of a VO2-rich bottom layer acting as the Mott transition switching layer and a V2O5/V2O3 mixed top layer acting as a control layer that suppresses any stray leakage current and improves cyclic performance. This bilayer structure enables excellent electric field-triggered Mott transition-based resistive switching of Pt-VOx-Pt metal-insulator-metal devices with a set/reset current ratio reaching 200, set/reset voltage of less than 2.5 V, and very stable DC cyclic switching upto 120 cycles with a great set/reset current and voltage distribution less than 5% of standard deviation at room temperature, which are specifications applicable for neuromorphic or memory device applications. [Figure not available: see fulltext.

Computational simulation of biomolecules transport with multi-physics near microchannel surface for development of biomolecules-detection devices.

PubMed

Suzuki, Yuma; Shimizu, Tetsuhide; Yang, Ming

2017-01-01

The quantitative evaluation of the biomolecules transport with multi-physics in nano/micro scale is demanded in order to optimize the design of microfluidics device for the biomolecules detection with high detection sensitivity and rapid diagnosis. This paper aimed to investigate the effectivity of the computational simulation using the numerical model of the biomolecules transport with multi-physics near a microchannel surface on the development of biomolecules-detection devices. The biomolecules transport with fluid drag force, electric double layer (EDL) force, and van der Waals force was modeled by Newtonian Equation of motion. The model validity was verified in the influence of ion strength and flow velocity on biomolecules distribution near the surface compared with experimental results of previous studies. The influence of acting forces on its distribution near the surface was investigated by the simulation. The trend of its distribution to ion strength and flow velocity was agreement with the experimental result by the combination of all acting forces. Furthermore, EDL force dominantly influenced its distribution near its surface compared with fluid drag force except for the case of high velocity and low ion strength. The knowledges from the simulation might be useful for the design of biomolecules-detection devices and the simulation can be expected to be applied on its development as the design tool for high detection sensitivity and rapid diagnosis in the future.

Moon base reactor system

NASA Technical Reports Server (NTRS)

Chavez, H.; Flores, J.; Nguyen, M.; Carsen, K.

1989-01-01

The objective of our reactor design is to supply a lunar-based research facility with 20 MW(e). The fundamental layout of this lunar-based system includes the reactor, power conversion devices, and a radiator. The additional aim of this reactor is a longevity of 12 to 15 years. The reactor is a liquid metal fast breeder that has a breeding ratio very close to 1.0. The geometry of the core is cylindrical. The metallic fuel rods are of beryllium oxide enriched with varying degrees of uranium, with a beryllium core reflector. The liquid metal coolant chosen was natural lithium. After the liquid metal coolant leaves the reactor, it goes directly into the power conversion devices. The power conversion devices are Stirling engines. The heated coolant acts as a hot reservoir to the device. It then enters the radiator to be cooled and reenters the Stirling engine acting as a cold reservoir. The engines' operating fluid is helium, a highly conductive gas. These Stirling engines are hermetically sealed. Although natural lithium produces a lower breeding ratio, it does have a larger temperature range than sodium. It is also corrosive to steel. This is why the container material must be carefully chosen. One option is to use an expensive alloy of cerbium and zirconium. The radiator must be made of a highly conductive material whose melting point temperature is not exceeded in the reactor and whose structural strength can withstand meteor showers.

Measurements of the force fields within an acoustic standing wave using holographic optical tweezers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bassindale, P. G.; Drinkwater, B. W.; Phillips, D. B.

2014-04-21

Direct measurement of the forces experienced by micro-spheres in an acoustic standing wave device have been obtained using calibrated optical traps generated with holographic optical tweezers. A micro-sphere, which is optically trapped in three dimensions, can be moved through the acoustic device to measure forces acting upon it. When the micro-sphere is subjected to acoustic forces, it's equilibrium position is displaced to a position where the acoustic forces and optical forces are balanced. Once the optical trapping stiffness has been calibrated, observation of this displacement enables a direct measurement of the forces acting upon the micro-sphere. The measured forces aremore » separated into a spatially oscillating component, attributed to the acoustic radiation force, and a constant force, attributed to fluid streaming. As the drive conditions of the acoustic device were varied, oscillating forces (>2.5 pN{sub pp}) and streaming forces (<0.2 pN) were measured. A 5 μm silica micro-sphere was used to characterise a 6.8 MHz standing wave, λ = 220 μm, to a spatial resolution limited by the uncertainty in the positioning of the micro-sphere (here to within 2 nm) and with a force resolution on the order of 10 fN. The results have application in the design and testing of acoustic manipulation devices.« less

Assessing the potential roles of silicon and germanium phthalocyanines in planar heterojunction organic photovoltaic devices and how pentafluoro phenoxylation can enhance π-π interactions and device performance.

PubMed

Lessard, Benoît H; White, Robin T; Al-Amar, Mohammad; Plint, Trevor; Castrucci, Jeffrey S; Josey, David S; Lu, Zheng-Hong; Bender, Timothy P

2015-03-11

In this study, we have assessed the potential application of dichloro silicon phthalocyanine (Cl2-SiPc) and dichloro germanium phthalocyanine (Cl2-GePc) in modern planar heterojunction organic photovoltaic (PHJ OPV) devices. We have determined that Cl2-SiPc can act as an electron donating material when paired with C60 and that Cl2-SiPc or Cl2-GePc can also act as an electron acceptor material when paired with pentacene. These two materials enabled the harvesting of triplet energy resulting from the singlet fission process in pentacene. However, contributions to the generation of photocurrent were observed for Cl2-SiPc with no evidence of photocurrent contribution from Cl2-GePc. The result of our initial assessment established the potential for the application of SiPc and GePc in PHJ OPV devices. Thereafter, bis(pentafluoro phenoxy) silicon phthalocyanine (F10-SiPc) and bis(pentafluoro phenoxy) germanium phthalocyanine (F10-GePc) were synthesized and characterized. During thermal processing, it was discovered that F10-SiPc and F10-GePc underwent a reaction forming small amounts of difluoro SiPc (F2-SiPc) and difluoro GePc (F2-GePc). This undesirable reaction could be circumvented for F10-SiPc but not for F10-GePc. Using single crystal X-ray diffraction, it was determined that F10-SiPc has significantly enhanced π-π interactions compared with that of Cl2-SiPc, which had little to none. Unoptimized PHJ OPV devices based on F10-SiPc were fabricated and directly compared to those constructed from Cl2-SiPc, and in all cases, PHJ OPV devices based on F10-SiPc had significantly improved device characteristics compared to Cl2-SiPc.

Introduction of automated blood pressure devices intended for a low resource setting in rural Tanzania.

PubMed

Baker, Elinor Chloe; Hezelgrave, Natasha; Magesa, Stephen M; Edmonds, Sally; de Greeff, Annemarie; Shennan, Andrew

2012-04-01

Regular blood pressure (BP) monitoring is a cost-effective means of early identification and management of hypertensive disease in pregnancy. In much of rural sub-Saharan Africa, the ability to take and act on accurate BP measurements is lacking as a result of poorly functioning or absent equipment and/or inadequate staff education. This study describes the feasibility of using validated automated BP devices suitable for low-resource settings (LRS) in primary health-care facilities in rural Tanzania. Following a primary survey, 19 BP devices were distributed to 11 clinics and re-assessed at one, three, six, 12 and 36 months. Devices were used frequently with high levels of user satisfaction and good durability. We conclude that the use of automated BP devices in LRS is feasible and sustainable. An assessment of their ability to reduce maternal and perinatal morbidity and mortality is vital.

A Trade Study and Metric for Penetration and Sampling Devices for Possible Use on the NASA 2003 and 2005 Mars Sample Return Missions

NASA Technical Reports Server (NTRS)

McConnell, Joshua B.

2000-01-01

The scientific exploration of Mars will require the collection and return of subterranean samples to Earth for examination. This necessitates the use of some type of device or devices that possesses the ability to effectively penetrate the Martian surface, collect suitable samples and return them to the surface in a manner consistent with imposed scientific constraints. The first opportunity for such a device will occur on the 2003 and 2005 Mars Sample Return missions, being performed by NASA. This paper reviews the work completed on the compilation of a database containing viable penetrating and sampling devices, the performance of a system level trade study comparing selected devices to a set of prescribed parameters and the employment of a metric for the evaluation and ranking of the traded penetration and sampling devices, with respect to possible usage on the 03 and 05 sample return missions. The trade study performed is based on a select set of scientific, engineering, programmatic and socio-political criterion. The use of a metric for the various penetration and sampling devices will act to expedite current and future device selection.

FACTS Devices Cost Recovery During Congestion Management in Deregulated Electricity Markets

NASA Astrophysics Data System (ADS)

Sharma, Ashwani Kumar; Mittapalli, Ram Kumar; Pal, Yash

2016-09-01

In future electricity markets, flexible alternating current transmission system (FACTS) devices will play key role for providing ancillary services. Since huge cost is involved for the FACTS devices placement in the power system, the cost invested has to be recovered in their life time for the replacement of these devices. The FACTS devices in future electricity markets can act as an ancillary services provider and have to be remunerated. The main contributions of the paper are: (1) investment recovery of FACTS devices during congestion management such as static VAR compensator and unified power flow controller along with thyristor controlled series compensator using non-linear bid curves, (2) the impact of ZIP load model on the FACTS cost recovery of the devices, (3) the comparison of results obtained without ZIP load model for both pool and hybrid market model, (4) secure bilateral transactions incorporation in hybrid market model. An optimal power flow based approach has been developed for maximizing social welfare including FACTS devices cost. The optimal placement of the FACTS devices have been obtained based on maximum social welfare. The results have been obtained for both pool and hybrid electricity market for IEEE 24-bus RTS.

Functional reasoning in diagnostic problem solving

NASA Technical Reports Server (NTRS)

Sticklen, Jon; Bond, W. E.; Stclair, D. C.

1988-01-01

This work is one facet of an integrated approach to diagnostic problem solving for aircraft and space systems currently under development. The authors are applying a method of modeling and reasoning about deep knowledge based on a functional viewpoint. The approach recognizes a level of device understanding which is intermediate between a compiled level of typical Expert Systems, and a deep level at which large-scale device behavior is derived from known properties of device structure and component behavior. At this intermediate functional level, a device is modeled in three steps. First, a component decomposition of the device is defined. Second, the functionality of each device/subdevice is abstractly identified. Third, the state sequences which implement each function are specified. Given a functional representation and a set of initial conditions, the functional reasoner acts as a consequence finder. The output of the consequence finder can be utilized in diagnostic problem solving. The paper also discussed ways in which this functional approach may find application in the aerospace field.

Mobile computing in critical care.

PubMed

Lapinsky, Stephen E

2007-03-01

Handheld computing devices are increasingly used by health care workers, and offer a mobile platform for point-of-care information access. Improved technology, with larger memory capacity, higher screen resolution, faster processors, and wireless connectivity has broadened the potential roles for these devices in critical care. In addition to the personal information management functions, handheld computers have been used to access reference information, management guidelines and pharmacopoeias as well as to track the educational experience of trainees. They can act as an interface with a clinical information system, providing rapid access to patient information. Despite their popularity, these devices have limitations related to their small size, and acceptance by physicians has not been uniform. In the critical care environment, the risk of transmitting microorganisms by such a portable device should always be considered.

Dual drain MOSFET detector for crosstie memory systems

NASA Astrophysics Data System (ADS)

Bluzer, N.

1985-03-01

This patent application, which discloses a circuit for detecting binary information in crosstie memory systems includes a dual drain MOSFET device having a single channel with a common source and an integrated, thin-film strip of magnetic material suitable for the storage and propagation of Bloch line-crosstie pairs acting as both a shift register and the device's gate. Current flowing through the device, in the absence of a magnetic field, is equally distributed to each drain; however, changing magnetic fields, normal to the plane of the device and generated by Bloch line-crosstie pairs in the strip, interact with the current such that a distribution imbalance exists and one drain or the other receives a disproportionate fraction of the current depending upon the direction of the magnetic field.

Review of Polyimides Used in the Manufacturing of Micro Systems

NASA Technical Reports Server (NTRS)

Wilson, William C.; Atkinson, Gary M.

2007-01-01

Since their invention, polyimides have found numerous uses in MicroElectroMechanical Systems (MEMS) technology. Polyimides can act as photoresist, sacrificial layers, structural layers, and even as a replacement for silicon as the substrate during MEMS fabrication. They enable fabrication of both low and high aspect ratio devices. Polyimides have been used to fabricate expendable molds and reusable flexible molds. Development of a variety of devices that employ polyimides for sensor applications has occurred. Micro-robotic actuator applications include hinges, thermal actuators and residual stress actuators. Currently, polyimides are being used to create new sensors and devices for aerospace applications. This paper presents a review of some of the many uses of polyimides in the development of MEMS devices, including a new polyimide based MEMS fabrication process.

Light up-conversion from near-infrared to blue using a photoresponsive organic light-emitting device

NASA Astrophysics Data System (ADS)

Chikamatsu, Masayuki; Ichino, Yoshiro; Takada, Noriyuki; Yoshida, Manabu; Kamata, Toshihide; Yase, Kiyoshi

2002-07-01

A photoresponsive organic light-emitting device combining blue-emitting organic electroluminescent (EL) diode with titanyl phthalocyanine as a near-infrared (IR) sensitive layer was fabricated. By irradiating near-IR light to the device, blue emission occurred in the lower drive voltage (between 5 and 12 V). The result indicates that the device acts as a light switch and/or an up-converter from near-IR light (1.6 eV) to blue (2.6 eV). The EL response times of rise and decay using a near-IR light trigger were 260 and 330 mus, respectively. At a higher voltage (above 12 V), enhancement of blue emission was observed with near-IR light irradiation. The ON/OFF ratio reached a maximum of 103.