This guidance describes FDA’s participation in the Voluntary Improvement Program (VIP). The VIP is a voluntary program intended to guide improvement to enhance the quality of devices.
The Voluntary Improvement Program (VIP), through the Medical Device Innovation Consortium (MDIC), evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals.
On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance,.