CDRH Seeks Participants for Manufacturing and Product Quality Pilot Program

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.