FDA proposes more efficient, transparent De Novo clearance pathway

The US Food and Drug Administration announced a proposal to establish procedures and criteria for the de novo classification of medical devices, including in vitro diagnostics. FDA Commissioner Scott Gottlieb said in a statement that the agency’s goal is to make the pathway “significantly more efficient and transparent by clarifying the requirements for submission and our processes for review.”

The agency uses the de novo pathway for review of novel, low- to moderate-risk devices for which no existing predicate exists that could be used to determine their substantial equivalence.

For low- to moderate-risk devices for which existing predicates exist, the FDA uses the 510(k) clearance pathway. Just last week, the agency announced that it is altering the 510(k) clearance pathway to rely less on comparisons with older predicate products already on the market.

While the FDA is modernizing its 510(k) pathway, the “de novo pathway provides a vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as the basis for future clearances,” Gottlieb said.

If it is finalized, the proposed de novo process rule will facilitate appropriate classification of new types of medical devices, the FDA said. The proposed regulations and requirements have been designed to provide structure, clarity, and transparency to the de novo classification process. They include requirements related to the format and content of de novo requests and processes and criteria for accepting, granting, declining, and withdrawing de novo requests.