Almost 20% of moderate-risk, nonimplantable, nonlife-sustaining therapeutic devices cleared by the FDA through its de novo pathway did not undergo a pivotal study, data show.
For this cross-sectional study, James L. Johnston, BS, a student at Yale School of Medicine, and colleagues reviewed publicly available FDA databases and decision summary documents to identify and characterize pivotal clinical studies on 63 devices the FDA cleared between Jan. 1, 2011, and Dec. 31, 2019. Most devices served a neurological purpose, but others could be used for gastroenterological, urological,
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