How do regulatory agencies ensure the release of a safe medical device?
This article describes the current regulatory activities of the Food and Drug Administration (FDA), in particular the FDA techniques for regulating medical-device approvals, medical-device reporting, and medical-device-company inspections. Also discussed are the FDA Modernization Act and the methods the FDA is using to implement the act.
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D018795:Device Approval / Q000331:legislation & jurisprudence; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D008722:Methods; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration