Industry Urges Caution In Response To Growing Push For 'Real-World' Device Evaluation System

07 Jun 2016

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.

FDA is stepping up efforts to develop and launch a new "national evaluation system" for devices that relies on shared-access registries, claims data, health records and other electronic data, but industry advocates are cautioning against moving too fast. Companies worry about unintended consequences and say more details are needed on how the broad-based initiative to expand availability of "real-world" evidence for devices will impact the medtech innovation cycle.

"In general, we support the concept," said Scott Whitaker, president and CEO of AdvaMed. But the details are important, Whitaker...