Negotiating Prices For Real-World Data Can Lower FDA Submission Costs, Shuren Says
This article was originally published in The Gray Sheet
A new national evaluation system for devices will provide collective bargaining power to reduce the costs of real-world data to substitute for clinical trials in company submissions.
You may also be interested in...
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.
CDRH Director Jeff Shuren says FDA is willing to foot the bill for a coordinating center to help launch a new "national device evaluation system," but it is contingent on a guarantee that the program would be funded by the upcoming user fee reauthorization.
Industry is increasingly supporting the "Sentinel" system for tracking postmarket product performance with claims and other real-world tools. But more companies need to be convinced of the value of the effort in advancing development of next-generation products, rather than simply a tool for safety surveillance, FDA Commissioner Robert Califf told members of the Alliance for a Stronger FDA.