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Experts: Expand FDA Authorities To Boost 510(k) Monitoring, Testing

By Beth Wang
October 23, 2019 at 5:29 PM
Experts from Harvard Medical School and Yale School of Medicine call for FDA to enhance postmarket evaluation and premarket testing of medical devices approved through the 510(k) pathway -- which would require more investment in technologies that leverage real-world data, and more authority for FDA to mandate postmarket studies and prohibit certain devices from being used as predicates in device clearances. Those efforts would require support from device makers and Congress, Vinay Rathi, research resident for Harvard Medical School’s Department...


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