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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review.
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 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 therefore takes on additional importance in both encouraging incoming quality applications from De Novo requesters and allowing the Agency to appropriately concentrate resources on complete applications.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-6069.