On October 5, 2021, FDA issued a final rule on the De Novo Classification Process. This final rule will add new regulations at 21 CFR Part 860, Subpart D--De Novo Classification that describe the procedures and criteria FDA will use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) contains the information necessary to permit a substantive review. This guidance provides recommendations with further detail regarding the types of information FDA believes are necessary to conduct a substantive review for a De Novo request, as well as recommendations regarding the acceptance 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. Moreover, with the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA agreed to performance goals based on the timeliness of reviews, as well as to issue guidance that includes a submission checklist to facilitate a more efficient and timely review process (see Section II.E. of the MDUFA IV Commitment Letter). Acceptance review is important in both encouraging incoming quality applications from De Novo requesters and allowing the Agency to appropriately concentrate resources on complete applications.