Pilot Program on Early PMA Critical-to-Quality Controls

FDA has announced a pilot program on “Approval Application Critical to Quality (PMA CtQ)” which aims to evaluate device design and manufacturing process quality information early in device development. The pilot is intended to provide qualifying PMA applicants with the option to engage FDA on developing CtQ controls and earn a waiver for standard PMA preapproval inspections.

In lieu of the pre-approval inspection, the agency says it would focus on the PMA applicant's implementation of the CtQ controls during a postmarket inspection. “PMA applicants can expect discussions during the inspection to relate to those factors most likely to impact device quality by working with FDA, before PMA approval, on defining activities critical to product and process quality,” it says. “Improvements in overall device quality may reduce device failures and recalls, and translate into more efficient utilization of resources for CDRH, ORA, and the device industry.”