Jonathan J. Darrow, SJD, LLM, JD, MBA; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH
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JAMA. 2021;326(5):420-432. doi:10.1001/jama.2021.11171
This Special Communication reviews the development of laws and standards affecting the evaluation and oversight of medical devices by the US Food and Drug Administration (FDA) and the outcomes of this regulatory system from 1976 to 2020.
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Audio Clinical Review:
FDA Regulation and Approval of Medical Devices