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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Medical Devices: FDA's 510(k) Operations Could Be Improved: PEMD-88-14

Medical Devices: FDA's 510(k) Operations Could Be Improved: PEMD-88-14

U. S. Government Accountability Office (G

Paperback

General Political Science

ISBN10: 1289010552
ISBN13: 9781289010553
Publisher: Bibliogov
Published: Jun 26 2013
Pages: 116
Weight: 0.49
Height: 0.24 Width: 7.44 Depth: 9.69
Language: English
In response to a congressional request, GAO examined the Food and Drug Administration's (FDA): (1) implementation of the premarket notification provision of the Medical Device Amendments of 1976; and (2) day-to-day operations in making its determinations of substantial equivalence.

GAO found that: (1) although FDA guidance for determining substantial equivalence was generally adequate and consistent with the less restrictive reading of the act, its description of performance assessment contained some ambiguities; (2) differences among the reviewing divisions within the Office of Device Evaluation (ODE) concerning manufacturer information suggested a lack of clear office-wide policy and coordination; (3) documentation of premarket notifications was inadequate to evaluate ODE compliance with formal review policy; (4) because of implementation problems, certain classes of medical devices did not meet requirements appropriate to their classification and FDA relied on premarket notifications to control market access to them; and (5) FDA reliance on products marketed prior to 1976 to determine substantial equivalence could cause problems.

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