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Device Lawyers: Performance Criteria Could Improve 510(k) Process

By David Roza
February 8, 2019 at 2:08 PM
Device industry lawyers believe FDA’s move toward allowing use of objective performance criteria to evaluate certain new medical devices, rather than relying on predicate devices, could improve the agency’s 510(k) process by creating a more streamlined pathway for well-understood devices. Bethany Hills, chair of the FDA practice at Mintz Levin, and Jeffrey Shapiro, a director at Hyman, Phelps & McNamara, both applauded FDA’s efforts to update the program, with Hills telling Inside Health Policy the pathway could be helpful...


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