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FDA Proposes More Efficient, Transparent De Novo Clearance Pathway

NEW YORK (GenomeWeb) – The US Food and Drug Administration today 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 today.

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.

The proposal builds on FDA's earlier de novo process work. In 1997, through the Food and Drug Administration Modernization Act, the agency was first able to classify novel, low- to moderate-risk devices without a predicate as a class I or class II device through de novo classification. In 2012, under the Food and Drug Administration Safety and Innovation Act, the FDA modified the de novo process to make it more streamlined and efficient. Then, in 2017, the agency issued final guidance on the process for the submission and review of a de novo request.

Since the FDA began granting marketing authorization for de novo devices, it has granted marketing authorizations for 235 medical devices through the pathway.

The proposed rule issued today is available for public comment and will not be in effect until finalized, the FDA said.