Medical Technology:

Quality Assurance Systems and Global Markets

PEMD-93-15: Published: Aug 18, 1993. Publicly Released: Sep 24, 1993.

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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.

GAO found that: (1) premarketing regulation and quality assurance for medical devices in the United States, Canada, and Japan vary somewhat, but function similarly; (2) the three countries are taking steps to improve medical devices and international competitiveness and harmonize their regulatory requirements; (3) the proposed EEC and U.S. regulatory systems have sufficient differences that could impede market access; (4) the EEC system does not approve new devices on the basis of compatibility with existing devices; (5) the EEC and U.S. systems differ on device classification; (6) the proposed EEC regulatory system emphasizes enhanced production and exchange of medical devices throughout EEC, whereas the proposed U.S. regulatory system emphasizes device safety and effectiveness; (7) 39 percent of U.S. medical device manufacturers are unaware of global market or EEC challenges to their industry; and (8) most U.S. manufacturers, except large and medium multinational manufacturers, are focusing on the domestic market, since they are not prepared to compete in the single market.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: FDA established a special unit to focus on international standards, regulatory developments, and markets.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Not Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Task Force on the European Economic Community Internal Market


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