The US Food and Drug Administration (FDA) requires that high-risk (class III) medical devices undergo premarket approval (PMA) review, the most stringent path through which devices enter the market. Since 1994, in an effort to enable breakthrough technology to reach market faster, the FDA has also offered priority review.1 There is a paucity of data on the speed and effectiveness of regulatory review in these expedited pathways.2 We compared priority vs standard PMA review with regard to review times, device recalls, and adverse events.
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Ong C, Ly VK, Redberg RF. Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices. JAMA Intern Med. 2020;180(5):801–803. doi:10.1001/jamainternmed.2020.0297
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