Industry Urges Caution In Response To Growing Push For 'Real-World' Device Evaluation System
This article was originally published in The Gray Sheet
AdvaMed's new chief Scott Whitaker says industry doesn't want to sign onto a new "national evaluation system" for devices championed by FDA until it is convinced that the initiative will enhance, rather than hinder, premarket product development.
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Patient advocacy groups unanimously thanked FDA and industry for including patient engagement and real-world evidence elements in the new user-fee deal during a Nov. 2 meeting. RWE was initially a point of disagreement during negotiations between FDA and industry, but industry cautiously supported pilot funding.
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.
The most popular online stories last month in The Gray Sheet included a "Compliance Corner" piece on nightmare scenarios firms have experienced during facility inspections; a scoop on the new chief of device evaluations at FDA; and our coverage of the dynamic regulatory situation in Europe.