FDA Seeks Comments on Medical Device Improvement Program Paperwork
Published Date: 10/1/2026
Notice
Summary
The FDA is asking for public feedback by November 2, 2026, on its Voluntary Improvement Program (VIP), which helps medical device makers improve quality through third-party reviews. This program supports better products and safer devices without adding extra costs or deadlines for companies. It’s all about encouraging excellence and teamwork between the FDA, industry, and partners like the Medical Device Innovation Consortium.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Reporting time burden on third-party appraisers
FDA estimates the reporting burden for the VIP as: 300 site manufacturer application responses totaling 24 hours (0.08 hours each), 4 aggregate data reports totaling 32 hours (8 hours each), and 300 summaries of site appraisals totaling 6,000 hours (20 hours each), for a combined annual total of 6,056 hours. The OMB control number is 0910-0922.
Voluntary program aims to improve device safety
The FDA’s Voluntary Improvement Program (VIP) supports third-party appraisals to help medical device makers improve product quality and produce safer devices. The notice says this supports better products and safer devices without adding extra costs or deadlines for companies and is facilitated by the Medical Device Innovation Consortium (MDIC).
Program limited to eligible CDRH manufacturers
Only eligible manufacturers of medical devices regulated by the Center for Devices and Radiological Health (CDRH) whose marketing applications are reviewed under the Federal Food, Drug, and Cosmetic Act—specifically sections 510(k), 513, 515, and 520—may participate in the VIP.
FDA will not publish appraisal benchmark data or require standard forms
FDA states it does not plan to make de-identified, aggregated benchmark data from VIP appraisals publicly available and will not require a common application form, standardized delta reports, or pre-populated fields from FDA databases for submissions. VIP remains a voluntary program and uses individualized appraisal approaches.
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