Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program

The FDA’s Center for Devices and Radiological Health (CDRH) is issuing this draft guidance to describe its policy regarding FDA’s participation in the Voluntary Improvement Program (VIP). The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices. The VIP builds on the framework piloted through FDA’s 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) and incorporates some of the successes and learnings from the pilot. This voluntary program is currently only available to eligible manufacturers of medical devices regulated by CDRH and whose marketing applications are reviewed under the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (including under sections 510(k), 513, 515, and 520).