On December 28, 2018, FDA announced its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program). This program is voluntary and intends to evaluate product and manufacturing quality within the medical device ecosystem and explore the effectiveness of a quality maturity appraisal, the use of objective metrics, optimization of resources, and impact on quality culture. The pilot program seeks to demonstrate better patient safety and outcomes, a lower regulatory burden on demonstrating quality assurance, and assure safety and effectiveness during product development and manufacturing.
- FDA engaged McKinsey to analyze device quality issues, and the finding were published in the 2011 “Understanding Barriers to Quality” white paper.
- FDA launched the Case for Quality in 2011 to elevate the focus of all medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes. FDA also developed Case for Quality public forums.
- In September 2014, FDA awarded the contract for the CfQ project to the Medical Device Innovation Consortium (MDIC). This was the first public-private partnership created with the sole objective of advancing medical device regulatory science.
- Through collaboration with the MDIC over the last 2 years, a maturity model and appraisal system (Capability Maturity Model Integration (CMMI) system) that can be adapted for the medical device industry was selected for the CfQ Pilot Program. This is a proven maturity model that will allow medical device organizations may measure their capability to produce high quality devices and increase patient safety. This measurement can then be used by the organization to drive targeted continuous improvement activities throughout their facility.
- This pilot program runs from January 2, 2018, to December 28, 2018. Participation criteria are included in the Federal Register Notice.
- The pilot is limited to a maximum of nine (9) participants. Participants are responsible for covering their own appraisals’ costs.
- Enrolled participants commit to engage early with CDRH and are required to submit baseline metrics before and during the appraisal to monitor their progress.
- Although this pilot program is open to nine participants, the FDA will look for ways to engage in discussions with firms that requested to participate but were not officially selected for participation.
- By participating in the pilot program, FDA intends to forego conducting surveillance inspections for participating manufacturing sites, but will still conduct “For Cause” inspections where appropriate.
- The program will include premarket, production, and postmarket metrics.
- The program will be administered by the CMMI Institute via third party team certified by the CMMI Institute.
- The CMMI Institute will share the results of their appraisal with the manufacturer and develop a summary report to share with CDRH.
- Data collected with help inform FDA on how to modify its requirements around surveillance and preapproval inspections, as well as the content of premarket manufacturing submissions so they can better allocate resources and potentially reduce the regulatory burden to appraised firms.