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

By U.S. Government Accountability Office

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.

• Format: Paperback
• Language: English
• ISBN: 1289010552
• ISBN13: 9781289010553
• Release Date: June 2013
• Publisher: Bibliogov
• Length: 116 Pages
• Weight: 0.49 lbs.
• Dimensions: 0.2" x 7.4" x 9.7"