Medical Device Recalls: Examination of Selected Cases
PEMD-90-6
Published: Oct 19, 1989. Publicly Released: Nov 06, 1989.
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Highlights
Pursuant to a congressional request, GAO provided information on the overall characteristics of medical device recalls, focusing on those that: (1) involved medical devices that the Food and Drug Administration (FDA) approved through its pre-market approval process (PMA) for marketing and subsequently recalled; and (2) FDA classified as class I, the most serious health risk.
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Consumer protectionFood and drug lawHealth hazardsMedical equipmentMedical suppliesProduct evaluationProduct recallsProduct safetyReporting requirementsSafety standards