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# Combination Product Application User Fees
- URL: https://www.fdaweb.com/combination-product-application-user-fees/
- Published: 2024-07-16T12:00:00.000Z
- Updated: 2026-09-14T14:35:35.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5157355

FDA has published a guidance, *Application User Fees for Combination Products*, explaining how fees are assigned for combination products reviewed in a single application or separate applications for each component. The [document](https://www.fda.gov/media/76413/download?ref=fdaweb.com) says the guidance replaces one issued in 4/2005 to provide consistency with current user fee programs and revisions to the combination product provisions in the Federal Food, Drug, and Cosmetic Act (FFDCA).

The guidance does not apply to combination products that are the subject of an application submitted under section 505(j) of the FFDCA or section 351(k) of the Public Health Services Act. Thus, FDA says, application fees under GDUFA and BsUFA are not addressed. The guidance also does not apply to PDUFA prescription drug program fees.