FDA plan to limit old predicates not happening soon, 510(k) regulator says

Dive Brief:

FDA is not going to take action to limit use of old 510(k) predicates anytime soon, Marjorie Shulman, the assistant director of 510(k)s at FDA, told lawyers Thursday at the Food and Drug Law Institute's annual conference.
The career staffer said a rigid decision to cut off use of old predicates at a specific age would "be awful" and would have unintended consequences for devices that do not change over time.
Center for Devices and Radiological Health Director Jeff Shuren told MedTech Dive the agency is still collecting stakeholder comment on its request for information but said the goal of its proposal was to shift firm behavior to relying on newer predicates, not necessarily removing older predicates.

Dive Insight:

FDA's comments come as welcome relief to device makers, which have raised concern FDA’s proposal to overhaul the 510(k) program by encouraging use of newer predicates would disrupt the industry.

Many medical device manufacturers have expressed concern about FDA’s proposal to potentially sunset certain 510(k) predicates, Michele Buenafe, a medical device attorney at Morgan, Lewis & Bockius, who participated on a FDLI panel, said.

FDA already pulled back from its initial proposal last November. That proposal floated the idea of limiting predicate use to products from the last 10 years. In the agency’s request for information, which closes May 22, FDA acknowledges that relying on certain older predicates may “not only be appropriate but necessary.”

Shuren agreed Thursday many technologies such as ultrasound gel simply have no need for changes.

"We're waiting for public comment. It's not the idea that we're enamored with; it is trying to nudge the industry more and more to keep making better products," Shuren said. "We have to determine between where there are safety concerns versus driving towards safer more effective product. The predicate proposal was about the latter."

Shulman said that the plan to limit use of older predicates may not be "totally off the table, but there are currently no plans" to implement it.