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GUIDANCE DOCUMENT

FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals Guidance for Industry and Food and Drug Administration Staff October 2017

Final
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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 notification submissions (510(k)s). 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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.