{"product_id":"medical-device-regulation-too-early-to-assess-european-systems-value-as-model-for-fda-hehs-96-65-9781289026547","title":"Medical Device Regulation: Too Early to Assess European System's Value as Model for FDA: HEHS-96-65","description":"\u003cp\u003e • Author(s): U. S. Government Accountability Office (\u003cbr\u003e • Publisher: Bibliogov\u003cbr\u003e • Publisher Imprint: Bibliogov\u003cbr\u003e • BISAC: General\u003c\/p\u003e\u003cp\u003ePursuant to a congressional request, GAO compared the Food and Drug Administration's (FDA) and the European Union's (EU) systems for reviewing and approving medical devices, focusing on: (1) key differences between the two systems; (2) the outputs of the two systems; and (3) the feasibility of FDA adopting features of the EU system. \u003cbr\u003e \u003cbr\u003e GAO found that: (1) U.S. and EU medical device regulatory systems share the goal of protecting public health, but the EU system is designed to facilitate EU-wide trade; (2) while EU reviews medical devices for safety and performance, FDA reviews devices for safety, effectiveness, and benefit to patients; (3) while EU gives major medical device regulatory responsibilities to public agencies and private organizations, FDA has sole responsibility over device regulation in the United States; (4) both systems link the level of medical review to device risk, but the two systems use different procedures to reach approval or clearance decisions; (5) questions and concerns have arisen regarding possible conflicts-of-interest in the EU medical device review process because EU notified bodies carry out a regulatory function within the EU medical device system and conflict-of-interest rules for EU reviewers are less comprehensive than in the United States; (6) sufficient data does not exist on the EU medical device review system to permit meaningful comparison with FDA because the EU system is new and not yet fully operational; and (7) it is too early to evaluate the impact of new FDA streamlined review procedures.\u003c\/p\u003e","brand":"Bibliogov","offers":[{"title":"Paperback","offer_id":47596695552151,"sku":"9781289026547","price":1563.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9781289026547.webp?v=1774994794","url":"https:\/\/atlanticbooks.com\/products\/medical-device-regulation-too-early-to-assess-european-systems-value-as-model-for-fda-hehs-96-65-9781289026547","provider":"Atlantic Books","version":"1.0","type":"link"}