Device Lawyer: 510(k) Plan Violates Statute, FDA ‘Too Big For Britches’

A device industry lawyer alleges that FDA’s proposals to reform its 510(k) process violates the agency’s statutory authority, threatens to monkey around with the device market, and would increase the cost of device innovation and health care more generally. The comments come as key device industry lobby groups raise strong concerns with the proposals, which came out Monday (Nov. 26), but so far stop short of saying they violate the law. Brad Thompson, a member of the firm at Epstein...