FDA to Pilot New High-Risk PMA for Medical Devices

September 13, 2017

The FDA is preparing a pilot program to improve the pre-market approval process for high-risk medical devices.

The agency is seeking nine companies to participate in its Premarket Approval Application Critical to Quality program. The goal is to streamline the PMA process to assure a firm’s quality system includes rigorous controls for features and characteristics considered critical to the safety and effectiveness of the device.

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.

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