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GUIDANCE DOCUMENT

User Fees for 513(g) Requests for Information Guidance for Industry and Food and Drug Administration Staff October 2022

Download the Final Guidance Document
Final
Docket Number:
FDA-2010-D-0144
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The Medical Device User Fee Amendments of 2022 (MDUFA V), 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, 2022, including requests for information under section 513(g) of the FD&C Act (“513(g) request”).  The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the medical device review process 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 assist FDA staff and regulated industry by describing the user fees associated with 513(g) requests.

Submit Comments

Submit Comments Online

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-2010-D-0144.

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