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Medical Device Regulation: Too Early to Assess European System's Value as Model for FDA: HEHS-96-65

by U. S. Government Accountability Office (
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Current price ₹1,563.00
Original price ₹1,770.00
Original price ₹1,770.00
Original price ₹1,770.00
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₹1,563.00
Current price ₹1,563.00

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Book cover type: Paperback
  • ISBN13: 9781289026547
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Bibliogov
  • Publisher Imprint: Bibliogov
  • Publication Date:
  • Pages: 56
  • Original Price: GBP 13.99
  • Language: English
  • Edition: N/A
  • Item Weight: 118 grams
  • BISAC Subject(s): General

Pursuant 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.

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.

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