Medical Device Regulation: Too Early to Assess European System's Value as Model for FDA
HEHS-96-65
Published: Mar 06, 1996. Publicly Released: Mar 06, 1996.
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Highlights
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.
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Comparative analysisConflict of interestsConsumer protectionInternational organizationsMedical equipmentPrivatizationProduct evaluationProduct safetySafety regulationMedicare