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GUIDANCE DOCUMENT

FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals Guidance for Industry and Food and Drug Administration Staff October 2017

Download the Final Guidance Document
Final
Docket Number:
FDA-2003-D-0378
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The Medical Device User Fee Amendments of 2017 (MDUFA IV), amended the Federal Food, Drug, and Cosmetic Act (the Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2017, including premarket approval applications (PMAs). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical device review process.

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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-2003-D-0378.

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