Showing 1 - 20 results of 75 for search '"Medical instruments and apparatus United States."', query time: 0.56s Refine Results
  1. 1
    Guidance for industry and FDA staff : expedited review of premarket submissions for devices.
    Published 2008
    Subjects: “...Medical instruments and apparatus United States Evaluation....”
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  2. 2
    Guidance for industry : cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells (PBSCs).
    Published 2007
    Subjects: “...Medical instruments and apparatus United States Evaluation....”
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  3. 3
    Premarket assessment of pediatric medical devices.
    Published 2004
    Subjects: “...Medical instruments and apparatus United States Evaluation....”
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  4. 4
    Draft guidance for industry and FDA : consumer-directed broadcast advertising of restricted devices.
    Published 2004
    Subjects: “...Medical instruments and apparatus United States....”
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  5. 5
    Year 2000 computing challenge : compliance status information on biomedical equipment : statement of Joel C. Willemssen Director, Civil Agencies Information Systems Accounting and Information Management Division, before the Subcommittee on Oversight and Investigations and the Subcommittee on Health and Environment, Committee on Commerce, House of Representatives /
    Published 1999
    Subjects: “...Medical instruments and apparatus United States....”
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  6. 6
    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
    Subjects: “...Medical instruments and apparatus United States Evaluation....”
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  7. 7
    Bundling multiple devices or multiple indications in a single submission.
    Published 2007
    Subjects: “...Medical instruments and apparatus United States Evaluation....”
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  8. 8
    FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment.
    Published 2004
    Subjects: “...Medical instruments and apparatus United States Evaluation....”
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  9. 9
    Guidance for industry : "help-seeking" and other disease awareness communications by or on behalf of drug and device firms.
    Published 2004
    Subjects: “...Advertising Medical instruments and apparatus United States....”
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  10. 10
    Fiscal year 1991 reconciliation issues relating to durable medical equipment, clinical laboratory services, and other issues under the Medicare Program : hearing before the Subcommittee on Health of the Committee on Ways and Means, House of Representatives, One Hundred First Congress, second session, May 22, 1990.
    Published 1990
    Subjects: “...Medical instruments and apparatus United States....”
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  11. 11
    Food and Drug Administration : Methodologies for Identifying and Allocating Costs of Reviewing Medical Device Applications Are Consistent with Federal Cost Accounting Standards, and Staffing Levels for Reviews Have Generally Increased in Recent Years.
    Published 2007
    Subjects: “...Medical instruments and apparatus United States....”
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  12. 12
    In vitro diagnostic (IVD) device studies, frequently asked questions.
    Published 2007
    Subjects: “...Medical instruments and apparatus United States Testing....”
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  13. 13
    In vitro diagnostic (IVD) device studies, frequently asked questions.
    Published 2010
    Subjects: “...Medical instruments and apparatus United States Testing....”
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  14. 14
    Do cellular and other wireless devices interfere with sensitive medical equipment? : hearing before the Information, Justice, Transportation, and Agriculture Subcommittee of the Committee on Government Operations, House of Representatives, One Hundred Third Congress, second session, October 5, 1994.
    Published 1997
    Subjects: “...Medical instruments and apparatus United States....”
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  15. 15
    Medical device epidemiology and surveillance /
    Published 2007
    Subjects: “...Medical instruments and apparatus United States Safety measures....”
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  16. 16
    Guidance for industry : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals.
    Published 2002
    Subjects: “...Medical instruments and apparatus United States....”
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  17. 17
    Biomaterials Access Assurance Act of 1997 : hearing before the Subcommittee on Commercial and Administrative Law of the Committee on the Judiciary, House of Representatives, One Hundred Fifth Congress, first session, on H.R. 872 ... June 12, 1997.
    Published 1997
    Subjects: “...Products liability Medical instruments and apparatus United States....”
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  18. 18
    Marketing or medicine : are direct-to-consumer device ads playing doctor? : hearing before the Special Committee on Aging, United States Senate, One Hundred Tenth Congress, second session, Washington, DC, September 17, 2008.
    Published 2009
    Subjects: “...Medical instruments and apparatus United States Marketing....”
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  19. 19
    FDA medical product approvals : hearing before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, first session, August 8, 1995.
    Published 1997
    Subjects: “...Medical instruments and apparatus United States....”
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  20. 20
    Marketing or medicine : are direct-to-consumer device ads playing doctor? : hearing before the Special Committee on Aging, United States Senate, One Hundred Tenth Congress, second session, Washington, DC, September 17, 2008.
    Published 2009
    Subjects: “...Medical instruments and apparatus United States Marketing....”
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