On May 5, 2022, the FDA issued the draft guidance, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program. This draft guidance is not for implementation at this time. The draft guidance, when finalized, is intended to describe the FDA’s policy on its participation in the Voluntary Improvement Program. The Voluntary Improvement Program is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturers’ practices using third-party appraisals to enhance the quality of devices.
This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2022-D-0109.
Throughout 2018, the FDA and the Medical Device Innovation Consortium (MDIC) undertook a voluntary pilot program among medical device manufacturing sites to assess capability and performance of key business processes using a series of integrated best practices detailed in the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system. 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 tailored to the medical device industry, which was developed by the CMMI Institute and stakeholders through a partnership with MDIC.
The goal of a quality maturity appraisal is to provide participating medical device manufacturing sites with insights about strengths and potential opportunities for improvement across various business processes associated with achieving key quality and performance objectives. Together, participating sites and their respective appraisal team engage 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 and increased access for patients.
VIP 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, and in accordance with section 510(h)(4) of the Federal Food, Drug, and Cosmetic Act, which outlines factors to consider in determining risk-based inspectional planning, 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 how the FDA would prioritize surveillance and preapproval inspections for participants. Additional information from the appraisal process provided FDA with information that became part of certain regulatory submissions, which helped the participating sites allocate resources to innovation and improvement efforts.
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 policy, as outlined in the draft guidance issued on [date], for engaging with CfQVIP. This FDA policy, when finalized, will be based on the lessons learned from the FDA engagement with the Voluntary Medical Device Manufacturing and Product Quality Pilot Program.
For more information regarding the VIP and how manufacturing sites may apply to participate, please see https://cmmiinstitute.com/medicaldeviceapplication.
Resources and Information from MDIC
- Voluntary Manufacturing and Product Quality Program Results (MDIC)
- CAPA Process Improvement White Paper (MDIC)
- MDIC Accelerate Sustainable Capability (ASC) Pilot Study
For more information please contact the Case For Quality Staff at CaseForQuality@fda.hhs.gov.