David R. Challoner, MD, vice president for health affairs emeritus, University of Florida and chair of the Institute of Medicine (IOM) committee. Image source: The National Academy of Sciences

The Institute of Medicine's (IOM) recent recommendation to eliminate the 510(k) clearance process for medical devices has prompted a sharp exchange between its leaders and medical device manufacturers.

The 510(k) clearance process allows medical devices to enter the market if manufacturers can demonstrate that a “substantial equivalent” is already in use. In an IOM report released in late July, a committee of 13 stated their unanimous opinion that the clearance process does not ensure medical device safety and effectiveness. The committee recommended creating a new framework for medical device approval.

In an Aug. 15 interview, David R. Challoner, MD, chair of IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, discussed the origins of the 510(k), the committee’s findings and the subsequent industry response.

Challoner, vice president of health affairs at the University of Florida in Gainesville, said that when the law was first enacted in 1976, its backers' intent was to bring the industry under regulation, requiring new devices to undergo a premarket approval and giving the old ones a pass.

“In 1976, [legislators] were legitimately afraid, as was the industry, that if you all of a sudden had to test or retest every device already in the marketplace, it would bring the device economy to a screeching halt,” said Challoner. “They said every device on the market gets in free, and everything after gets a predicate to compare to. But we expect—and this was unsaid—that almost everything hence forward will somehow be tested and evaluated for safety and effectiveness.”

The lawmakers decided not to disrupt the 1976 marketplace because they assumed that older devices would eventually be replaced by new ones, Challoner said, but their expectation never came to fruition. “All the while, technology has been rapidly advancing, getting more complicated, and therefore, the substantial equivalence decision gets more and more tenuous.”

The IOM report was released after 18 months of work prompted by an FDA request to evaluate the effectiveness of the 35-year-old law, as well as consider whether or not it has promoted innovation. “We could find no evidence, other than opinion, that the 510(k) did or did not influence innovation,” Challoner said. “If they really want an answer to this question they need an evidence-based study.”

Challoner acknowledged that many manufacturers opposed the IOM recommendation, instead favoring recent FDA reforms to the 510(k) process.

“The device industry will tell you—even before you give them a conclusion—that any change from current practice is going to kill innovation. Well, that’s just nonsense,” Challoner said. “Basically, the industry would consider the shortest possible time frame for clearance as favoring innovation. But we have to develop some new paradigm by which the public’s legitimate interest based on safety and effectiveness is considered.”

One of the major IOM recommendations is to establish and implement post-market surveillance systems. These could allow less-complete premarket data gathering by industry, Challoner said, supplemented by a more complete and rapidly responding post-market assessment—a “defense early warning system.” Current post-market assessment is too weak, too scattered and lacks appropriately placed responsibility, Challoner said, adding that it is currently only used under particular conditions as required by the FDA.

When asked if there are any circumstances under which substantial equivalence is appropriate for device approval, Challoner said “not as long as substantial equivalence has nothing to do with safety and effectiveness.” However, under a possible new premarket  framework, it may be appropriate to consider post-market data of substantially equivalent devices.

“If the FDA had a post-market surveillance system in place, they could look at the safety and effectiveness data of a predicate device,” Challoner said. “That should be part of the evidence package for approving a new device.”

Now that the report has been released, it’s the responsibility of the FDA to manage the conversation, Challoner said, and it’s important that all stakeholders—industry, patient groups, healthcare providers, Congress, the FDA—participate in developing a clearance process for medical devices.

“Start the process, think about the performance characteristics, get all of the parties together, make a recommendation to Congress and get them to approve it,” Challoner said.

The FDA is scheduled to hold a public meeting on the IOM report on Sept. 16.