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Medical Devices: FDA Review Times, 1989 Through 1996

HEHS-97-146R Published: Jun 03, 1997. Publicly Released: Jun 03, 1997.
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Highlights

Pursuant to a congressional request, GAO provided information on the Food and Drug Administration's medical device review times, focusing the three major types of device submissions: (1) premarket notifications; (2) premarket approval (PMA) applications; and (3) PMA supplements.

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Health Care
Consumer protectionFood and drug lawManufacturing industryMedical equipmentMedical researchProduct evaluationProduct safetyRegulatory agenciesSafety regulationFood