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.
Recommendations for Executive Action
|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.|
|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.|