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Guidance Issuing OfficeCenter for Devices and Radiological Health
The Medical Device User Fee Amendments of 2017 (MDUFA IV) amended the Federal Food, Drug, and Cosmetic Act (the 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 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.
Performance goals were negotiated and agreed to under MDUFA IV for De Novo requests received in FY 2018-2022. These performance goals and process improvements are outlined in the MDUFA IV Commitment Letter from the Secretary of Health and Human Services (the Secretary) to Congress and are further described in the document.
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:
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-5712.