Kathryn Burke, Emergo Group
The U.S. Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device manufacturing following promising results of a pilot program.
The FDA guidance stems from a pilot undertaken by the agency along with the Medical Device Innovation Consortium (MDIC) in 2018. That preliminary effort was called the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, or CfQ Pilot Program.
The FDA’s Center for Devices and Radiological Health (CDRH) released this draft guidance to describe its participation in the Voluntary Improvement Program (VIP). The VIP, facilitated through the MDIC, evaluates the capabilities and performance of a medical device manufacturer. The practices are appraised by third parties to promote process improvement and improve medical device quality.
Based on the success of the pilot, the MDIC program activities and operations will transition into a permanent program, titled the Case for Quality Voluntary Improvement Program (CfQVIP). The FDA and MDIC collaborated to establish a charter and a governance committee for CfQVIP for the program.
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