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GUIDANCE DOCUMENT

User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications Guidance for Industry and Food and Drug Administration Staff December 2018

Final

User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications

Docket Number:
FDA-2009-D-0051
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

During the review of a premarket submission, the review clock is impacted by both FDA’s and Industry’s action. The Medical Device User Fee Amendments of 2017 (MDUFA IV), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act or 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) and certain biologics license applications (BLAs). 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. For more information on performance goals for PMAs, see the guidance “FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals Performance.”

Medical device user fees were initially authorized by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). Since MDUFMA was first enacted in 2002, it has been reauthorized three times (the Medical Device User Fee Amendments of 2007 (MDUFA II), the Medical Device User Fee Amendments of 2012 (MDUFA III), and the Medical Device User Fee Amendments of 2017 (MDUFA IV). The purpose of this guidance document is to identify: (1) the types of PMAs and BLAs subject to device user fees; (2) exceptions to user fees; and (3) the actions that may result in refunds of user fees that have been paid.

For information regarding bundling of multiple submissions, see “Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and Food and Drug Administration Staff.”


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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-2009-D-0051.