The FDA is preparing its new Premarket Approval Application Critical to Quality pilot program, created to give PMA applicants the option to speak with the FDA on development of CtQ controls for their devices and to forego the standard PMA pre-approval inspection.
As part of the voluntary program, which launches later this month, the agency will focus on the PMA applicant’s implementation of the CtQ controls during a more intense post-market inspection that shines a spotlight on design, manufacturing, and quality assurance practices.
The program is part of the agency’s Case for Quality effort to apply innovative strategies that promote quality in medical devices instead of focusing only on compliance via the Quality System regulation. It’s a joint effort between CDRH and the Office of Regulatory Affairs.
Starting Sep. 29, FDA will open the applications process for the new program, accepting the first nine participants with submissions that meet the acceptance criteria. The pilot program will run from then to Dec. 31, 2018. After that, said Kotz, the FDA will assess the pilot to determine next steps.