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US FDA Maturity Model Pilot Program Gets October Meeting Date

 
• By David Filmore

The agency wants to hear public feedback on its plan to employ a standardized model to measure a company's manufacturing "maturity" via third-party assessments to support regulatory and compliance decisions.

US FDA is convening a workshop at its Maryland headquarters on Oct. 10 to discuss its plans for a pilot project that would use third-party assessors to measure the maturity of a company's manufacturing systems to help shape the agency's regulatory, compliance, and enforcement decisions.

The agency has been working closely with the Medical Device Innovation Consortium to adapt the well-established "Capability Maturity Model Integration" program to the device industry to measure the extent to...

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