De Novo Requests: FDA Finalizes Three Guidances

Regulatory NewsRegulatory News | 06 September 2019 |  By 

The US Food and Drug Administration (FDA) on Friday finalized three guidance documents related to de novo classification requests for medical devices.

Devices using the de novo classification process are those for which there is no predicate device to rely on, and devices granted a de novo request can serve as a predicate device for a later 510(k) submission. So far in 2019, CDRH has granted 15 de novo requests, which compares with 44 requests granted in 2018 and 31 in 2017.

One of the guidances finalized Friday deals with the criteria the agency intends to use in assessing whether a request for an evaluation of automatic class III designation should be accepted for a full review.

In terms of changes from the draft version, initially released in October 2017, the final guidance includes new sections for de novo requestors of combination products, explaining when patent certification information needs to be provided for de novo requesters of combination products containing an approved drug as a constituent part.

In a section on whether a device type is eligible for a de novo classification, FDA also adds clarification for situations in which multiple reviews are underway for the same device type.

“We do not anticipate that De Novo requests for the same device type from different requesters will frequently be under review concurrently. If a De Novo request for the same device from a different requester is currently under review at the time another De Novo request for the same device type is submitted to the Agency, this fact alone would not result in a ‘Refuse to Accept’ decision,” the final guidance says.

FDA also reiterates that industry and FDA will have 60 days to operationalize the policies within this guidance.

“Therefore, if all criteria necessary to meet a minimum threshold of acceptability for De Novo requests as outlined in this guidance are not included in a De Novo request received by FDA before or up to 60 days after the publication of this guidance, FDA staff does not generally intend to refuse to accept,” the guidance adds.

Other Guidances

FDA also finalized guidance on Friday on user fees related to de novo requests, which began under the Medical Device User Fee Amendments of 2017 (MDUFA IV). The guidance explains “(1) the types of De Novo requests subject to user fees; (2) exceptions to user fees; and (3) the actions that may result in refunds of user fees that have been paid.”

The third guidance finalized by FDA on Friday deals with the different actions FDA may take on de novo requests, the effect each action has on goals under MDUFA IV for de novo requests received in FY 2018-2022 (see below) and the different industry actions that may be taken on de novo requests.


Acceptance Review for De Novo Classification Requests
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals

User Fees and Refunds for De Novo Classification Requests

Webinar - Acceptance Review for De Novo Classification Requests: Final Guidance - September 18, 2019


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