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Pilot Of New US Evaluation System Will Include At Least Two Devices

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.

At least one PMA and one 510(k) product type will need to be piloted on the nascent US National Evaluation System for health Technology (NEST) by fiscal year 2019 under a draft agreement between FDA and industry.

The NEST system is being developed by FDA and private- and public-sector partners to capture real-world evidence from a robust...

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