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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The Medical Device Innovation Consortium has chosen industry veteran Simon Mason to lead the National Evaluation System for health Technology Coordinating Center, an MDIC initiative to advance the use of real-world evidence in regulatory approvals.
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.