Opportunity
Federal Register #FDA2026N6655
FDA Public Meeting on Medical Device User Fee Amendments (MDUFA) Reauthorization
Buyer
Food and Drug Administration
Posted
July 08, 2026
Respond By
August 05, 2026
Identifier
FDA2026N6655
This opportunity is an announcement from the Food and Drug Administration (FDA) regarding a public meeting on the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2028-2032. - Government Buyer: - Department of Health and Human Services, Food and Drug Administration (FDA) - OEMs and Vendors: - FDA is the only OEM or vendor mentioned - Replimune, Inc. is referenced as the applicant for a Biologics License Application, not as a vendor for procurement - Products/Services Requested: - No products, part numbers, or purchase quantities are requested - Services include: - Public meeting for MDUFA reauthorization (stakeholder presentations, public comments) - Advisory committee meeting for Biologics License Application 125827 (Vusolimogene Oderparepvec by Replimune, Inc.) - Unique or Notable Requirements: - Focus on legislative and stakeholder engagement process for MDUFA reauthorization - Opportunity for public input and comment - Emphasis on performance goals, patient engagement, digital health, real-world evidence, and international harmonization - Section 508 compliance required for submitted materials - No procurement of goods or services is solicited in this notice; it is informational and participatory in nature
Description
The Food and Drug Administration (FDA) is announcing a hybrid public meeting titled "Medical Device User Fee Amendments." The meeting aims to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2028 through 2032. MDUFA authorizes FDA to collect fees and use them for the review of device applications. The current legislative authority expires September 30, 2027, requiring new legislation for continuation. The public meeting will be held in person and virtually on August 5, 2026, from 10 a.m. to 3 p.m. Eastern Time, with a 30-day comment period following publication.