FDA to Launch PMA Pilot Program This Month

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… Read More

FDA Guidance Aims to Improve Demographic Data for Devices

The FDA released guidance to help the medical device industry analyze and report clinical study data on age, racial and ethnic subgroups, noting there is… Read More

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