USA – De Novo Requests: FDA Finalizes Three Guidances

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…