Federal Register #FDA-2026-N-7492

FDA Announces Medical Device User Fee Rates and Outsourcing Facility Fees for FY 2027

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has announced official fee rates and payment procedures for medical device user fees and outsourcing facility fees for fiscal year 2027. - Government Buyer: - Food and Drug Administration (FDA), Office of Financial Management - Medical Device User Fees: - Standard premarket application fee: $636,732 - Panel-track supplement fee: $509,386 (80% of standard) - De Novo classification request fee: $191,020 (30% of standard) - 180-day supplement fee: $95,510 (15% of standard) - Real-time supplement fee: $44,571 (7% of standard) - 510(k) premarket notification submission fee: $28,653 (4.5% of standard) - 30-day notice fee: $10,188 (1.6% of standard) - 513(g) request for classification information fee: $8,596 (1.35% of standard) - Annual fee for periodic reporting on a Class III device: $22,286 (3.5% of standard) - Annual establishment registration fee: $13,785 - Outsourcing Facility Fees: - Small business establishment fee: $7,142 - Non-small business establishment fee: $22,074 - Reinspection fee: $21,427 - Notable Requirements: - Small businesses may qualify for reduced fees or waivers - Payment methods include online (Pay.gov) and wire transfer - Fees apply to device manufacturers, processors, and outsourcing facilities - No specific OEMs or vendors are named; fees are regulatory and apply to all qualifying entities - Period of Performance: - Fees are effective for fiscal year 2027 (October 1, 2026, through September 30, 2027) - The notice does not request products or services but sets regulatory fees for industry compliance.

Description

The Food and Drug Administration (FDA) announces the fee rates and payment procedures for medical device user fees for fiscal year 2027. These fees apply from October 1, 2026, through September 30, 2027, and include fees for certain medical device submissions, periodic reports, and establishment registrations. The notice details how fees were determined, payment methods including online payments and wire transfers, and eligibility for small business fee reductions. The total revenue amount for FY 2027 is set at $418,343,000 before inflation adjustments, with adjusted base fees for premarket applications and establishment registrations provided.

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