Docket Number:
FDA-2003-D-0033
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 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.

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All written comments should be identified with this document's docket number: FDA-2003-D-0033.