FDA to pilot new high-risk PMA for medical devices


FDAThe U.S. FDA is readying a pilot program to try and improve the pre-market approval process for high-risk medical devices later this month.

The federal safety watchdog is seeking nine companies to participate in its Premarket Approval Application Critical to Quality program beginning Sept. 29 and running to either Dec. 31, 2018, or until nine PMAs have enrolled. The goal is to streamline the PMA process “while assuring that a firm’s quality system includes rigorous controls for features and characteristics considered critical to the safety and effectiveness of the device,” the FDA said.

Rather than undergo pre-approval inspections, participants in the PMA CtQ program would agree to post-approval inspections focused on design, manufacturing and quality assurance criteria developed in collaboration with the FDA.

Get the full story on our sister site MassDevice.

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