The QMN Weekly Bulletin
Quality / Medical Devices / Regulatory Affairs / QSR / Inspections and Audits

CDRH Seeks Participants for Manufacturing and Product Quality Pilot Program

Jan. 19, 2018
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CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing.

The center, which began accepting applications for the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program on Jan. 2, intends to select manufacturers that can represent the medical device industry.

Participants must have remained in good FDA compliance during the last five years, and they must agree to: Appraisals conducted by the CMMI Institute; collecting and submitting metric data; being available for real-time consultations; participating in monitoring activities; and allowing the institute to report performance data analyses to the FDA.

Data collected throughout the duration of the pilot, which will run until Dec. 28, may also be used “to help determine if changes to the pilot program need to be made, de-identify data for benchmarking and trending, and to adjust any benefits to the firms where appropriate,” FDA spokesperson Deborah Kotz told FDAnews.

Participants will work in collaboration with the institute, agency staff, and the Medical Device Innovation Consortium (MDIC), which collectively developed the Capability Maturity Model Integration (CMMI) system, a maturity and appraisal program for the medical device industry.

The CMMI system’s goal is to “help organizations discover the true value they can deliver by building capability in their people and processes,” the FDA said. It has been “successfully used in various industries, including information technology, healthcare, automotive, defense, and aerospace to consistently deliver high quality products and reduce waste and defects,” the agency said.

According to the MDIC, there are several benefits for participating companies, such as having products reach the market at a faster pace, as well as improving resource allocation. Boston Scientific estimated participating in this program could have allowed it to redeploy $500,000 of resources assigned for the 69 30-day notices it submitted in 2016, the consortium said.

The CfQ Program was also designed to benefit the FDA by potentially reducing the allocation of resources, as participating firms can get inspection waivers.

“The idea of just routinely going out to do an audit for a company doing quite well...is probably not the best utilization of the agency’s limited resources,” Robin Newman, director at CDRH’s Office of Compliance said during the 2017 CfQ program workshop.

“It would be much better to go out and use those resources in areas where situations are not under control.”

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