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Some FDA device approvals do not include pivotal study

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.

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