510(k) Overhaul Gaining Momentum at FDA

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 Last April, the FDA issued a “draft guidance” and a document, “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.”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.”

Also, Better Post-Market Surveillance

Gottlieb’s FDA is piloting what it hopes will be a faster, more real-world post-market adverse event reporting system. The new system, called the National Evaluation System for Health Technology (NEST), is run by an independent governing body, the NEST Coordinating Council (NESTcc).

“To date,” Gottlieb and Shuren said in another posted commentary on November 20, “the NESTcc has entered into agreements this year with 12 organizations that represent more than 195 hospitals and almost 4,000 outpatient clinics with access to more than 495 million patient records—which will all be a part of the early data network.”

In September, FDA added $3 million to the seed funding for NEST, and asked Congress for an additional $46 million in fiscal year 2019 to build up NEST and to investigate post-market problems with individual devices. As of December 12, that additional $6 million is uncertain; FDA’s budget is caught in the middle of the President’s tug-of-war with Congress over the Mexican border wall.

Dumping MAUDE

NEST may seem like “Oh, well, yet another government database nobody looks at.” However, it may be different. Harm from medical devices is a hot button with the public.

On the very same day Gottlieb announced his intention to overhaul the 510(k) system, the Associated Press and NBC were publishing the results of a year-long medical device investigation conducted by the International Consortium of Investigative Journalists and more than 50 other media partners around the world.

One of those stories described how six medical devices (two of them orthopedic—spinal cord stimulators and hip prosthesis) out of more than 190,000 were responsible for a quarter of all the medical-device-related injuries and deaths reported to the Food and Drug Administration (FDA) from 2008 to 2017.

Currently, FDA logs reported adverse events into the MAUDE (Manufacturer and User Facility Device Experience) database—which Gottlieb admits is an incomplete and clumsy system. NEST, by contrast, is intended to accept not only reports from patients and caregivers, but also extract medical device problems from such sources as Medicare reimbursement procedure data—a gigantic, rich data mine. In the long run, a portion of higher medical device user fees would help pay for it.

“De Novo” Rule Change Also Proposed

In another change, the FDA is proposing a new pathway for “De Novo” and other devices. The proposed regulation was issued for public review and comment on December 7, 2018.

Currently, “De Novo” devices are automatically slotted under the Class III designation. The FDA wants to change that. Since many De Novo devices are noninvasive consumer products, the new rule would provide a pathway for commercialization as Class I or Class II devices. Incidentally (hint, hint) the comment period ends March 7, 2019.