Bradley Merrill Thompson Quoted in “Device Lawyer: 510(k) Plan Violates Statute, FDA ‘Too Big for Britches'”Inside Health Policy November 29, 2018
Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “Device Lawyer: 510(k) Plan Violates Statute, FDA ‘Too Big for Britches,’” by David Roza. (Read the full version – subscription required.)
Following is an excerpt:
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 Becker Green, alleges in an email to Inside Health Policy that FDA’s ideas, such as publishing a proposed list of devices using predicates more than 10 years old; sunsetting the use of certain older predicates in favor of more modern ones; and moving away from substantial equivalence and towards standardized safety and performance criteria, “violate the law.”
“It seems that FDA is getting too big for its britches,” the lawyer writes. “A regulatory agency is not imbued with the power to create law outside of the parameters set by Congress,” he adds.