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De Novo Classification Process (Evaluation of Automatic Class III Designation) Guidance for Industry and Food and Drug Administration Staff October 2021

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
OMB Control No. 0910-0844
Expiration Date:  1/31/2025

The purpose of this document is to provide guidance on the process for the submission and review of a De Novo classification request (hereafter a "De Novo request") under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the De Novo classification process. This process provides a pathway to class I or class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.

Submit Comments

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:

Dockets Management
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-2011-D-0689.

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