Life Sciences

FDA issues draft guidance on user fees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New FDA draft guidance includes user fee and user-fee refund information for 30-day notices and periodic reports, as well as modified user-fee refund provisions for modular premarket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The FDA will accept comments on the draft guidance until April 13.