Not enough warning. GAO report finds FDA's medical device monitoring lacking.
Hensley
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D018795:Device Approval / Q000331:legislation & jurisprudence*; D005069:Evaluation Studies as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration* / Q000592:standards