Pilot Of New US Evaluation System Will Include At Least Two Devices
Executive Summary
New details about the planned pilot launch of the National Evaluation System for health Technology were included in US FDA's recently posted user-fee reauthorization commitment letter. At least one PMA and one 510(k) product type must be piloted on the real-world evidence system. Device center director Jeff Shuren continued to tout the program at this year's AdvaMed conference.
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