Federal Register #FDA-2026-N-6876

FDA Requests Public Comment on Medical Device Voluntary Improvement Program Information Collection

This opportunity involves a request for public comment from the Food and Drug Administration (FDA) regarding information collection for the Medical Device Voluntary Improvement Program (VIP). - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - OEMs and Vendors: - Medical Device Innovation Consortium (MDIC) (facilitator, not an OEM) - No specific OEMs or commercial vendors are named as product or service providers - Products/Services Requested: - No procurement of products or services is requested - The notice seeks public comment on information collection activities related to the VIP - Information to be collected includes: - Site manufacturer applications - Aggregate data reporting - Summaries of site appraisals - Unique or Notable Requirements: - The VIP is a public-private partnership to improve medical device manufacturing quality - Participation is open to manufacturers regulated by FDA's CDRH whose marketing applications are reviewed under the Federal Food, Drug, and Cosmetic Act - The FDA is specifically seeking feedback on the necessity, accuracy, and burden of the proposed information collection - No purchase, contract, or procurement action is being solicited

Description

The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information related to the Medical Device Voluntary Improvement Program (VIP). This program involves third-party appraisals of medical device manufacturers to evaluate and improve their quality and performance. Eligible manufacturers regulated by the FDA's Center for Devices and Radiological Health (CDRH) may participate. The FDA estimates the burden of this information collection and invites comments on its necessity, accuracy, and ways to minimize respondent burden.

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