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Highlights

Pursuant to a congressional request, GAO compared U.S. policies and procedures and quality assurance requirements for marketing medical devices to those of Japan, Canada, and the European Economic Community (EEC), focusing on: (1) similarities and differences; (2) compatibility; (3) the U.S. medical device industry's preparedness for global market competition; and (4) the U.S. industry's response to the EEC single market.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services 1. The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to increase the internal coordination, outreach, and focus on small manufacturers of its educational and guidance programs for exporting.
Closed - Implemented
FDA established a special unit to focus on international standards, regulatory developments, and markets.
Other 2. The Chairman of the Task Force on EEC Internal Market, in cooperation with the Secretary of Commerce, should make a targeted effort to inform U.S. medical device manufacturers on progress toward the single market and changes related to harmonization that may affect their competitiveness.
Closed - Not Implemented
HHS's response, dated December 22, 1993, indicates that it will continue to work with medical device manufacturers and the international regulatory community to facilitate international trade in medical devices.

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