On November 26, 2018, FDA Commissioner Scott Gottlieb, M.D. announced plans to formally propose and seek comments on a major overhaul of the 510(k) medical device clearance process.
Eighty-two percent of all medical devices reach the market under the pre-market notification rules of Section 510(k) of the Food, Drug, and Cosmetics Act. The FDA has wanted to overhaul the 510(k) process for a long time. This year, however, the long discussed “overhaul” appears to be accelerating. Last April, the FDA issued a “draft guidance” and a document, “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.”
Is FDA trying to change the definition of “predicate device”?
“Data show that nearly 20 percent of current 510(k)s are cleared based on a predicate (a prior device) that’s more than 10 years old, said a joint statement by Gottlieb and Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health (CDRH), posted on the FDA website November 26. “That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.”
Gottlieb added, in a long November 27 followup: “We want to create policy vehicles that will move the market toward reliance on newer predicates that reflect more modern characteristics related to their safety and performance. Among the immediate steps we’re seeking are to make public information about cleared devices that demonstrated substantial equivalence to older predicate devices, focusing on those that use predicates that are more than 10 years old. We’ll seek public feedback on whether predicates older than 10 years are the right starting point and if there are other actions we should take to advance the use of modern predicates.”
