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GUIDANCE DOCUMENT

Application User Fees for Combination Products Guidance for Industry and FDA Staff July 2024

Final Level 2 Revised Guidance
Docket Number:
FDA-2004-D-0371
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products

This document provides guidance to industry and FDA staff on application user fees for combination products as defined under 21 CFR 3.2(e). Combination products may be reviewed in a single application or in separate applications for the constituent parts, as appropriate. The guidance explains that combination products for which a single application is submitted should be assessed the applicable user fee associated with that particular type of application. The document also addresses how the Agency applies user fees for combination products when separate applications are submitted for the constituent parts. If the applicant chooses to submit two applications for a cross-labeled combination product, each would be assessed the applicable user fee for each application. In the infrequent situation when FDA determines that a single application is not appropriate and separate applications are warranted, the guidance describes how the total application fee amount might be reduced when the applicant qualifies for certain waiver provisions under the Prescription Drug User Fee Act (PDUFA) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).


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:

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-2004-D-0371.

Questions?

Contact Point
Combination Products Guidance Contact
Office of Combination Products
combination@fda.gov
301-796-8930
301-847-8619
 
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