$30m In Device User Fees Will Go To Real-World Evidence Evaluation System

FDA will get $30m in device industry user fees over five years to help fund broader use of real-world evidence for devices in the US.

The agency and industry negotiators announced a draft MDUFA IV agreement last month, which will form the basis of the user-free program that stretches from fiscal years 2018 through 2022. (Also see "Industry, US FDA Strike $1Bn Deal After Contentious User-Fee Negotiations" - Medtech Insight, 23 August, 2016.) The agreement includes support for a pilot program of the FDA-championed National Evaluation System for health Technology (NEST) program, envisioned as a collaborative effort for vetting, validating, and employing registries and databases to continuously assess device safety and performance