FDA Seeks Feedback on Voluntary Device Improvement Program
Published Date: 7/17/2026
Notice
Summary
The FDA wants your thoughts on a new plan to collect info from medical device makers who join a Voluntary Improvement Program. This program aims to help companies improve their devices without extra paperwork stress. If you’re involved in making or managing medical devices, you’ve got until September 15, 2026, to share your feedback—no fees, just your voice!
Analyzed Economic Effects
5 provisions identified: 3 benefits, 1 costs, 1 mixed.
Estimated annual reporting burden
FDA estimates the VIP information collection will produce a total annual burden of 6,056 hours across listed activities: site manufacturer applications — 300 responses at 0.08 hours each (24 hours); aggregate data reporting — 4 responses at 8 hours each (32 hours); and summaries of site appraisals — 300 responses at 20 hours each (6,000 hours).
Estimated burden reduced from prior estimate
FDA states its estimated burden for this collection reflects a decrease of 2,009 hours and a decrease of 200 responses compared to its prior estimate, an adjustment attributed to device registration/listing data and informal stakeholder feedback.
Who may join the Voluntary Program
If you make medical devices, only eligible manufacturers whose marketing applications are reviewed under the Federal Food, Drug, and Cosmetic Act sections 510(k), 513, 515, or 520 may participate in the FDA's Voluntary Improvement Program (VIP). The VIP participation rules and eligibility are described in the FDA guidance titled "Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program."
Third‑party appraisals sent to FDA
As part of the VIP, third‑party appraisers evaluate participating manufacturers and the FDA will receive information about participating manufacturers' capability and performance from those appraisals. The VIP is facilitated by the Medical Device Innovation Consortium (MDIC).
Public comment opportunity and deadline
If you are involved in making or managing medical devices, you may submit comments on the proposed information collection by September 15, 2026, via https://www.regulations.gov or by mail to FDA's Dockets Management Staff. The notice explains how to submit confidential versus public comments.
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Key Dates
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