FDA makes minor revisions on user fees, refunds for PMAs, device biologic license applications

The FDA made minor revisions to the final guidance document “User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications,” according to a press release.

The release noted revisions to the guidance document incorporate information on device biologics license applications from the guidance document “Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products.” Portions of the assessing user fees guidance have been previously superseded by the “Bundling Multiple Devices or Multiple Indications in a Single Submission” and “Real-Time Premarket Approval Application (PMA) Supplements” guidance documents. According to the press release, the minor revisions made to the “User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications” guidance means the assessing user fees guidance is now entirely superseded and will be removed from the FDA website.

Intended to help the medical device industry determine the appropriate fees for their applications, the release noted the guidance document identifies the types of premarket approval applications and device biologic license applications subject to device user fees. Exceptions to user fees are also listed, as well as the actions that may result in refunds of user fees that have been paid.

Reference:

www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm345633.pdf?utm_campaign=fda%20makes%20minor%20revisions%20to%20final%20guidance%20on%20user%20fees&utm_medium=email&utm_source=eloqua