FDA issues draft guidance on user fees
Device Regulation Alert: Safety, Compliance and Reimbursement News, March 30, 2009
New FDA draft guidance includes user fee and user-fee refund information for 30-day notices and periodic reports, as well as modified user-fee refund provisions for modular premarket approval applications (PMAs).
The guidance identifies:
- Types of PMAs subject to user fees
- Types of PMAs that are not subject to user fees because they are expressly excluded from fees under the act
- Actions that may result in refunds of user fees that have been paid
The FDA will accept comments on the draft guidance until April 13.
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