Case for Quality: CDRH’s Pilot Program Name Change


In 2018, MDIC supported CDRH’s Voluntary Medical Device Manufacturing and Product Quality Pilot Program which simplifies regulatory requirements for medical device manufacturers who practice and demonstrate mature quality practices.  As we’ve seen this pilot gain momentum throughout the past year, CDRH, MDIC, and CMMI aim to scale the pilot into a full program in 2019. At the Case for Quality (CfQ) forum in November, we discussed the future of the program and discussed one of the biggest challenges with this pilot: the name. Voluntary Medical Device Manufacturing and Product Quality Pilot is a long title for a program. The reality is that no one ever remembers it, and it doesn’t truly capture what this innovative program is about, and what it could be in the future.  With the opportunity for growth, we’re delighted to announce that the CDRH Voluntary Medical Device Manufacturing and Product Quality Pilot Program will be changing its name to the Case for Quality Voluntary Improvement Program (CFQ VIP) in 2019.

The MDIC Case for Quality Steering Committee launched a new working group in January that will guide the development of this expanded program. In addition, this name change will allow us to present this highly innovative and quality-focused program to stakeholders across the medical device ecosystem. By renaming the program, we believe that we will be better able to share with the ecosystem how a shift from a compliance mindset to an emphasis on quality provides better outcomes for the industry and patients.

Our next Case for Quality Forum is February 25, 2019 in San Diego, CA. At this first Forum of 2019, we’ll discuss the updates on the Case for Quality Voluntary Improvement Program, including regulatory incentives for 510K manufacturers. Visit MDIC’s events web page to register for the forum. Also, if you missed our final MDICx webinar on the pilot in December, the slides and video are now available here.