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User Fees and Refunds for De Novo Classification Requests 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

During the review of a premarket submission, the review clock is impacted by both FDA's and Industry's actions. The Medical Device User Fee Amendments of 2017 (MDUFA IV), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2017, including De Novo classification requests (De Novo requests). The additional funds obtained from user fees enable FDA, with the cooperation of industry, to meet certain performance goals and implement improvements for the medical device review process as outlined in the letter from the Secretary of Health and Human Services to Congress.

The purpose of this guidance document is to identify: (1) the types of De Novo requests subject to user fees; (2) exceptions to user fees; and (3) the actions that may result in refunds of user fees that have been paid. This document also incorporates MDUFA IV process improvements.

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-2017-D-5713.

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