FDA Wants to Modernize 510(k) Trials

December 3, 2018

The FDA says it wants to modernize device clinical trials by using more up-to-date technologies as comparators to make sure only the safest, most effective devices get to market.

Low- to moderate-risk medical devices have long been able to coast to approval by demonstrating they’re equivalent to already-approved or “predicate” devices. But regulators say too many predicate devices are decades old.

“When new devices rely on older predicates, they may not be accounting for… the latest advances in technology that could benefit patients,” Commissioner Scott Gottlieb said in a statement issued last week.

Last year, the FDA approved nearly 3,200 devices through the easier 510(k) pathway — more than 80 percent of all approvals. Nearly 20 percent of the devices approved between 2015 and 2018 relied on predicates that were at least 10 years old.

It’s a system that’s “long overdue” for an update, says Mark Summers, president of patient engagement for WCG and a former device company executive.

“It’s come to be viewed as a way to try to shoehorn a device into predicate status as a way to get streamlined approval,” Summers tells CenterWatch. “That wasn’t the original intent of it. It’s really gotten out of hand over the years and I think device executives are really doing a disservice to themselves.”

It’s not just that the safety risks increase by rushing devices through approval — many manufacturers, such as sleep apnea device makers, find that they can’t get CMS or private insurance approval for 510(k) devices because they lack clinical data to support reimbursement.

“From that standpoint, I think the medical device industry is doing itself a disservice when they try to game the 510(k) process,” Summers says.

To push device sponsors to use more modern comparators, the FDA says it’s considering publishing a list of devices that relied on older technology for approval. It’s also seeking public comments on how best to handle predicates.

The agency is walking a fine line here. It stresses that it doesn’t believe that older predicates are unsafe or that they should be pulled from the market. But it’s convinced that newer technologies for device trials “would help the overall product environment continue to evolve in the direction toward more modern performance standards.”

The FDA issued draft guidance in April as part of what the agency called its “Medical Device Safety Action Plan.” Its key goals: to streamline and modernize postmarket fixes for already-approved devices, improve device safety, “advance” device cybersecurity and consolidate some of its regulatory functions.

The agency says its calls for reform were driven by the increasing complexity of the gadgets they regulate. Newer devices are more often interconnected and interoperable, which means they introduce all kinds of new considerations, such as cybersecurity threats.

“Older devices that rely on wireless communication may not incorporate the latest protections against interference from other technologies,” Gottlieb said. “And older devices that incorporate radiofrequency or laser technology may not meet the newer consensus standards adopted by the FDA.”  

-By Bill Myers