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Showing 1 - 20 results of 51 for search 'Dept. of Health and Human Services,', query time: 0.22s Refine Results
  1. 1
    Public health notifications.
    “...Dept. of Health and Human Services, U.S. Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document Database
  2. 2
    Information sheet guidance for IRBs, clinical investigators, and sponsors : significant risk and nonsignificant risk medical device studies.
    Published 2006
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
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    Government Document eBook
  3. 3
    Information sheet guidance for IRBs, clinical investigators, and sponsors : frequently asked questions about medical devices.
    Published 2006
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
  4. 4
    Annual report of the Office of Science and Technology.
    Published 1985
    “...U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration...”
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    Government Document Microform Serial
  5. 5
    Guidance for industry : financial disclosure by clinical investigators.
    Published 2001
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
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    Government Document eBook
  6. 6
    Guidance for industry. electronic signatures, scope and application.
    Published 2003
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
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    Government Document eBook
  7. 7
    Guidance for industry : "help-seeking" and other disease awareness communications by or on behalf of drug and device firms.
    Published 2004
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  8. 8
    Guidance for industry : presenting risk information in prescription drug and medical device promotion.
    Published 2009
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  9. 9
    Guidance for industry : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals.
    Published 2002
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
    Get full text
    Government Document eBook
  10. 10
    Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
  11. 11
    User fees and refunds for premarket approval applications.
    Published 2009
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
  12. 12
    Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
  13. 13
    Guidance for industry : somatic cell therapy for cardiac disease.
    Published 2009
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
    Get full text
    Government Document eBook
  14. 14
    Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
  15. 15
    Guidance for industry and FDA staff : expedited review of premarket submissions for devices.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
  16. 16
    In vitro diagnostic (IVD) device studies, frequently asked questions.
    Published 2007
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
  17. 17
    Bundling multiple devices or multiple indications in a single submission.
    Published 2007
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
  18. 18
    Annual reports for approved premarket approval applications (PMA).
    Published 2006
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
  19. 19
    Real-time premarket approval application (PMA) supplements.
    Published 2006
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
  20. 20
    Requests for inspection by an accredited person under the Inspection by Accredited Persons Program authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002.
    Published 2005
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
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