FDA User Fee Programs Explained: PDUFA, MDUFA, GDUFA

Assurentry Team · February 2026

Overview of FDA User Fees

FDA collects user fees from industry to fund review of applications and facility inspections. Congress authorizes these programs periodically. Key programs include PDUFA, MDUFA, GDUFA, and BsUFA.

PDUFA: Prescription Drug User Fees

The Prescription Drug User Fee Act (PDUFA) funds human drug and biologic application review. Sponsors pay application fees for NDAs, BLAs, and supplements. Establishment and product fees also apply. See registration fees for broader context.

MDUFA: Medical Device User Fees

MDUFA supports device application review (510(k)s, PMAs, De Novo) and facility registration. Annual registration fees apply to device establishments. Small businesses may qualify for fee reductions.

GDUFA: Generic Drug User Fees

GDUFA applies to ANDA sponsors and API and finished dose form facility fees. Fee amounts and due dates are published annually. Fee waivers or reductions exist for certain circumstances.

Planning for Fees

Monitor FDA fee announcements each fiscal year. Budget for application, establishment, and product fees. Missing fee payments can delay review or result in refuse-to-file determinations.