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FDA Looks For Diverse CMMI 'Maturity' Pilot Enrollees; Device-Makers Expect Big Savings

 
• By Elizabeth Orr

The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program – designed to gauge the manufacturing maturity of device-makers – to smaller firms, officials said at a recent industry meeting. Medtronic and Edwards Lifesciences, in particular, noted that using the Capability Maturity Model Integration (CMMI) appraisal framework could allow them to save hundreds of thousands of dollars in FDA submissions and 30-day notice fees, among other expenses.

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[Editor’s Note: This article was updated Oct. 17 to reflect the fact that participants in the pre-pilot phase did not pay for appraisals; to clarify the process by which appraisers are being selected for the upcoming pilot; and to remove suggestion that the pilot will employ a five-tiered maturity scale.]

US FDA is looking at ways to enroll a more diverse range of companies in its new Voluntary Medical Device Manufacturing and Product Quality Program, which aims to gauge the...

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