In 1997, US Congress established the US Food and Drug Administration (FDA) De Novo premarket review pathway for novel low-risk and moderate-risk medical devices.1 In recent years, the FDA and medical device manufacturers have increasingly used the De Novo pathway; the FDA cleared 65 devices via this pathway between 1997 and 2012 and an additional 187 between 2013 and 2019.2-4 Devices cleared through the De Novo pathway represent novel technologies, and approval may serve as the basis for subsequent clearance of devices through the 510(k) pathway.5 The 510(k) pathway requires manufacturers to demonstrate that new devices are “substantially” equivalent to previously cleared devices, typically without clinical studies demonstrating safety or effectiveness. This study characterizes the premarket clinical evidence supporting clearance of moderate-risk therapeutic devices cleared through the De Novo pathway and postmarket experience, including FDA-required postmarket studies, recalls, and subsequent 510(k) clearances.
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Johnston JL, Dhruva SS, Ross JS, Rathi VK. Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019. JAMA Intern Med. Published online October 12, 2020. doi:10.1001/jamainternmed.2020.3214
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