Voluntary Medical Device Manufacturing and Product Quality Pilot Program

Throughout 2018, the FDA and the Medical Device Innovation Consortium (MDIC) undertook a voluntary pilot program among medical device manufacturing sites to assess their product quality. During the pilot program, the Capability Maturity Model Integration (CMMI) Institute certified third-party teams to conduct quality system maturity appraisals. The appraisals were conducted using a maturity appraisal model applicable to the medical device industry, which was developed by the CMMI Institute and stakeholders through a partnership with MDIC.

Appraisals

The goal of a quality maturity appraisal is to provide participating medical device manufacturing sites with insights about their level of maturity in various process areas and to identify areas of improvement. Together, participating sites and their respective appraisal team engaged in a journey of continuous improvement through quarterly check-ins designed to discuss and report progress and growth – resulting in improved processes and medical device quality, which ultimately leads to better patient outcomes.

Quality appraisals promote continuous improvement and organizational excellence among participating medical device manufacturing sites. During the pilot program, participating sites committed to engage with CDRH and submit baseline metrics after the appraisal to monitor their progress on a quarterly basis. Participant sites covered their own appraisals’ costs.

For this pilot program, the FDA considered the prior history of compliance at the site, the firm’s commitment to continuous improvement, and the data collected through the appraisal to determine whether surveillance and preapproval inspections could be waived. Additional information from the appraisals allowed the FDA to accept streamlined content for premarket manufacturing submissions, which helped the participating sites to better allocate more resources to innovation and improvement efforts

Results

The FDA and MDIC have evaluated the 2018 pilot activities, and the pilot results are available on the MDIC website.

Based on the success of the pilot, the MDIC program activities and operations are transitioning 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 in anticipation of transitioning to a permanent program.

The FDA is currently in the process of developing a complementary permanent program to engage with CfQVIP. This FDA program will be based on the lessons learned from the FDA engagement with the Voluntary Medical Device Manufacturing and Product Quality Pilot Program.

Resources and Information from MDIC

Questions

For more information please contact the Case For Quality Staff at [email protected].