FDA Guidance Details Criteria for Assessing De Novo Requests

Posted September 12, 2019

The Food and Drug Administration (FDA) has issued final guidance detailing the procedures and criteria it will use in when evaluating applications under the agency’s De Novo classification pathway, a way for new technologies to obtain marketing authorization as a Class I or II medical device rather than automatically receiving a Class III designation.

The guidance, Acceptance Review for De Novo Classification Requests, satisfies the agency's commitment, as documented in the Medical Device User Fee Amendments of 2017 (MDUFA IV), to put forth "performance goals based on the timeliness of reviews, as well as guidance that includes a submission checklist to facilitate a more efficient and timely review process."

"Focusing the Agency’s review resources on complete De Novo requests will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible," wrote the FDA, adding that acceptance review encourages "incoming quality applications from De Novo requesters" and allows the agency to better manage resources.

The guidance includes an Acceptance Checklist that the FDA intends to use as an objective means of ensuring that De Novo requests are suitable to proceed to substantive review. The FDA advised submitting a completed checklist with any De Novo request.

The document also guides FDA staff on "Refuse to Accept" decisions. Agency staff are instructed to consider whether requesters provided a rationale in the Acceptance Checklist for why requested information is not applicable to a device.

"FDA will not consider a given criterion in the checklist to be 'present' if the De Novo request fails to include either the information requested or a rationale for omission or deviation," wrote the agency.

Distinguishing between the acceptance and substantive reviews is important, wrote the FDA. The Acceptance Checklist is an objective tool for determining whether a request contains the information needed to conduct a substantive review, while the substantive review is the stage at which "the quality of content" will be assessed—not during the checklist phase.

With the release of this final guidance, the agency revised the following related guidance documents to reflect its new policies surrounding acceptance review of De Novo requests:

The FDA will hold a Sept. 18 a webinar to provide information and answer questions regarding the final guidance, which the agency said may take up to 60 days to implement.