{"product_id":"medical-devices-u-s-government-accountability-office-9781289010553","title":"Medical Devices: FDA's 510(k) Operations Could Be Improved: PEMD-88-14","description":"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. \u003cbr\u003e \u003cbr\u003e 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.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e U. S. Government Accountability Office (\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1289010552\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781289010553\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Bibliogov\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 06\/26\/2013\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 116\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.49lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.69h x 7.44w x 0.24d","brand":"U. S. Government Accountability Office (","offers":[{"title":"Paperback","offer_id":47611409826047,"sku":"9781289010553","price":19.75,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_83781e25-140c-4115-8f5b-08750068ecf6.jpg?v=1764513701","url":"https:\/\/www.whiterainbookhouse.com\/products\/medical-devices-u-s-government-accountability-office-9781289010553","provider":"WR Book House","version":"1.0","type":"link"}