FDA Finalizes De Novo Evaluation Guidance, Proposes Acceptance Criteria

The FDA finalized guidance on the evaluation process for De Novo classification requests and issued draft guidance on the acceptance criteria.

The final guidance, first drafted in August 2014 to update the agency’s 1998 policy, provides a pathway for Class I or Class II classifications. It includes updated recommendations on two interactions between industry and agency staff during the De Novo classification process — the optional pre-submission interaction for obtaining feedback on a request prior to submission, and the De Novo request.

The agency issued a separate summary document on the two options for De Novo classification of devices with low or moderate risk, one for devices that have received a Not Substantially Equivalent determination in response to a 510(k) submission, and another for devices for which there is no existing device to assess substantial equivalence.

The guidance includes the criteria agency staff will use when evaluating a De Novo request, and it describes when the review clock will stop while a request is placed on hold. For example, De Novo requests that lack sufficient information to determine whether there could potentially be existing predicate devices may be placed on hold.

The draft guidance outlines preliminary questions for the FDA’s initial review of a request, and the criteria agency staff will use in the acceptance review process It also includes a checklist for De Novo classification requests.

Read the final guidance here: www.fdanews.com/11-01-17-DeNovoClassificationProcess.pdf.

Read the draft guidance here: www.fdanews.com/11-01-17-AcceptanceReview.pdf. — Ana Mulero