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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.
Publisher : Bibliogov (June 26, 2013)
Language : English
Paperback : 116 pages
ISBN-10 : 1289010552
ISBN-13 : 978-1289010553
Item Weight : 7.8 ounces
Dimensions : 7.44 x 0.24 x 9.69 inches
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