User Fees and Refunds for Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs)

5 October 2022 — FDA published the final guidance on user fees and refunds for PMAs and device BLAs for industry and FDA staff.

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.

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