FDA is revamping clearance procedures for medical devices
U.S. agency to rely far less on comparisons with older products on the market
WASHINGTON— The Food and Drug Administration is significantly revamping the way it clears most medical devices for U.S. marketing, planning to rely far less on comparisons with much older products already on the market.
This reliance by the federal agency has been regarded as one of the weaknesses in the way it allows medical devices to be sold in the U.S., leading to problem devices like defective metal hip implants and bloodstream filters that fractured. Instead of insisting on full studies of such products, the FDA has allowed the standard to be “substantial equivalence” to already-cleared ones.
Some of the comparison products—known as “predicate devices”—were approved soon after the agency began regulating medical devices in 1976. More than 80% of medical devices in the U.S. have since gained market entry under this standard.
“It’s time to fundamentally modernize an approach first adopted in1976, when Congress considered the vast diversity of devices” entering the U.S. market, senior FDA officials said in a statement disclosed Monday. The officials are FDA Commissioner Scott Gottlieb and Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.
Drs. Gottlieb and Shuren said the agency plans to drive companies “toward reliance on more modern predicate devices or objective performance criteria.” Their plan is to shift companies, if they continue with the use of predicate devices, toward those no older than 10 years rather than the 40-year precedents now.
Jeffrey N. Gibbs, a medical-device attorney with the Washington firm Hyman, Phelps & McNamara, called the FDA action “a dramatic overhaul” and noted that some of the changes may require congressional action. He contends that the FDA hasn’t made a convincing case that this step is necessary.
By early 2019, the FDA plans to issue a guidance to the industry that will alternatively allow certain well-understood types of devices “to rely on objective safety and performance criteria” to get cleared onto the U.S. market.
Regarding comparison products, Dr. Gottlieb in an interview said some of them “don’t approximate what we would want to establish as modern standards. This represents a pretty aggressive vision to move the pool of predicates in the direction of new performance standards.”
Scott Whitaker, president and chief executive of the medicaldevice industry group AdvaMed, said that the “FDA acknowledges that its concern with older predicates only applies to a minority of devices and that those devices have no demonstrated safety concerns.” He said the group hopes that the FDA “will recognize that in some cases there are legitimate reasons for using older predicates, and that for some devices where the technology has changed little, using those older predicates still makes sense.”
The agency plans to post publicly a list of those devices that are based on comparisons more than 10 years old.
This comparison system of approving devices has faced considerable criticism over the years.
In 2011, for instance, a committee of the prestigious Institute of Medicine reported that the agency should stop using it entirely because the system “cannot assure that devices reaching the market are safe and effective.” Consumer groups and doctors focused on safety issues have been critical of the system known as the 501 (k) process, while the industry generally has defended it.
“Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old,” the FDA officials wrote, meaning that “some devices may not be continually improving.”
Drs. Gottlieb and Shuren, while defending this system, note that the most recent devices are complex, with features making them vulnerable to hackers, or are more automated, or employ robotics and advanced materials.
The 510(k) allows the agency to clear what it now estimates are 82% of medical devices under this less rigorous pathway. It generally doesn’t require gold-standard studies in which the product is compared with a placebo or active treatment control group.