CDRH Launches Manufacturing and Product Quality Pilot Program

By MedTech Intelligence Staff

The program intends to promote quality in medical device design and manufacturing.

Beginning today, FDA will choose up to nine applicants for a new Voluntary Medical Device Manufacturing and Product Quality Pilot Program. “The FDA believes that proactive engagement with medical device manufacturers and a focused inspectional approach will promote quality in device design and manufacturing,” according to an agency release.

The pilot program will use independent performance evaluations and identify quality-focused actions by manufacturers that have shown a history of good compliance through the medical device design and manufacturing process.

“The FDA intends to work collaboratively with the applicants to implement a pilot program that recognizes an independent assessment of design, manufacturing and product quality among medical device manufacturers.” –FDA

Third-party teams that are certified by the Capability Maturity Model Integration Institute will conduct quality system maturity appraisals, the cost of which is the responsibility of the program participants. The intent of the appraisals is to promote “continuous improvement and organizational excellence” among the participating manufacturing sites.

More details about the program are available on the Federal Register website.

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