Pivotal clinical studies were not done for 19% of 63 devices approved from 2011 to 2019 using FDA's de novo premarket review pathway, according to a research letter in JAMA Internal Medicine. "To ensure that better evidence is generated to guide clinical decision-making, the FDA could require that devices cleared through the de novo pathway meet prespecified effectiveness end points for clearance and that postmarket studies include larger patient populations," researchers wrote.
Some FDA device approvals do not include pivotal study
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