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FDA’s Final Rule Clarifies De Novo Pathway For Device Makers

By Kelly Lienhard / October 5, 2021 at 1:02 PM
FDA on Monday (Oct. 4) published a final rule that clarifies how medical device makers can pursue marketing authorization through the agency’s De Novo pathway for new low- to moderate-risk devices for which there’s no existing predicate comparison device. The rule, which goes into effect Jan. 3, 2022, aims to make the pathway more predictable for industry and encourage developers to bring new, important medical devices to market. The De Novo process has been around since 1997, but industry experts...


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