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  5. Voluntary Manufacturing and Product Quality Pilot Program
  1. Quality and Compliance (Medical Devices)

Voluntary Manufacturing and Product Quality Pilot Program

Voluntary Medical Device Manufacturing and Product Quality Pilot Program

Through this pilot program, launched in 2018, the Capability Maturity Model Integration (CMMI) Institute certified third-party teams to conduct quality system maturity appraisals. These appraisals used a maturity appraisal model applicable to the medical device industry, which was developed by CMMI and stakeholders through a partnership with the Medical Device Innovation Consortium (MDIC).

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

Receiving quality appraisals promote continuous improvement and organizational excellence among participating medical device manufacturing sites. Participating sites were committed to engage openly with CDRH and were required to submit baseline metrics after the appraisal to monitor their progress on a quarterly basis. Participant sites were responsible for covering their own appraisals’ costs.

Through this program, the FDA intended to forego conducting surveillance and preapproval inspections for participating manufacturing sites, reducing the burden and disruption such inspections may cause and allowed participants to shift resources to innovation and improvement efforts.

The 2018 pilot activities have been evaluated and the results are available on the MDIC website. The FDA is currently in the process of developing an operational program based on the concepts learned from the pilot.

For more information please contact the Case For Quality Staff at CaseForQuality@fda.hhs.gov.

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