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.
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As US FDA has been on a quest to encourage gathering more real-world data, companies like Medtronic and Johnson & Johnson seem to be hopping on the bandwagon with partnerships to gather and analyze how their products really perform.
A year after the NEST Coordinating Center was launched, the group has expanded its staff and now it wants to get a data network in place by year's end with real-world evidence information that device manufacturers can use to impress US FDA reviewers.
The agency issued a final guidance spelling out reasonable applications of real-world device evidence and what factors must be considered when weighing whether data collected from routine care via means – such as electronic patient records or insurance claims – can help support a product approval or other regulatory decision.