Opportunity
Federal Register #2026-20085
FDA seeks public comment on information collection for its medical-device manufacturer improvement program
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 01, 2026
Respond By
November 03, 2026
Identifier
2026-20085
The U.S. Food and Drug Administration is seeking public comment on an information collection for its Voluntary Improvement Program (VIP), not seeking to buy products or services. - Government buyer: Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS). - Purpose: The notice concerns an extension of information collection for the VIP, which supports participating medical-device manufacturers. - Program participants: Third-party appraisers evaluate manufacturers, and the Medical Device Innovation Consortium (MDIC) facilitates the program. - Information collected: Manufacturer applications, aggregate data reports, and site-appraisal summaries. - Estimated burden: FDA estimates 6,056 total reporting hours annually. - Procurement status: No products, quantities, or contract services are requested; no product or service line items are identified.
Description
The FDA submitted for OMB review and clearance an extension of its information collection supporting the Voluntary Improvement Program (VIP) for medical devices. The program uses third-party appraisers to evaluate participating manufacturers’ capabilities and performance, with the goal of guiding improvements to device quality. The collection includes manufacturer applications, aggregate data reporting, and summaries of site appraisals. Written comments were due by November 2, 2026.