The future "national evaluation system" that FDA envisions for devices can serve as a collective bargaining tool for cheaper access to real-world data to device companies' support of premarket and postmarket requirements, according to FDA Device Chief Jeffrey Shuren.
"Today you might have to have clinical data to get a new use for a device, for postmarket requirements, for a [Section] 522 study, or just to respond to adverse-event reports," Shuren, director of the Center for Devices and Radiological Health, said May 5 at the Medical Device Manufacturers
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