• Clin Perform Qual Health Care · Apr 1999

    How do regulatory agencies ensure the release of a safe medical device?

    • B Haggar.
    • Clin Perform Qual Health Care. 1999 Apr 1; 7 (2): 100-3.

    AbstractThis 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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