Medical Devices--Voluntary Improvement Program

The Voluntary Improvement Program (VIP) is facilitated by the Medical Device Innovation Consortium (MDIC), a public-private partnership that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals. The VIP is intended to guide improvement to enhance the quality of medical devices. As part of the VIP process, FDA receives information about participating device manufacturers’ capability and performance for activities covered in third-party appraisals to enhance manufacturing and business practices in a way that improves the quality and safety of medical devices, benefitting patients and consumers. While appraisals performed through the VIP do not constitute a new regulatory requirement or serve as an equivalent to an FDA inspection, FDA may consider information from a participant’s appraisals, as appropriate, in risk-based inspection planning.

The latest form for Medical Devices--Voluntary Improvement Program expires 2026-09-30 and is listed under ICR 202307-0910-005.

VIP - site manufacturing applications

Federal Enterprise Architecture: Health - Consumer Health and Safety