The U.S. Food & Drug Administration (FDA) plans to overhaul its controversial 510(k) program, amid criticism that the process missed safety issues associated with spinal-cord stimulator implants and many other dangerous medical devices.
The FDA’s 510(k) allows medical devices to come to market without undergoing human clinical trials, as long as a manufacturer can show that the new product is “substantially equivalent” to an older “predicate” device.
To be considered a predicate, the older medical devices must have undergone the FDA’s far more stringent premarket approval protocols. Among other things, that process requires human testing.
The FDA approved roughly 95% of the medical devices currently sold in the United States via the 510(k) program. Just last week, however, the Associated Press and other worldwide media outlets published a scathing investigative report that suggested the program missed safety problems associated with spinal-cord stimulators used to treat chronic pain.
Among other things, the FDA has received over 80,000 adverse event reports involving spinal-cord stimulator implants that have burned, shocked, or otherwise injured patients.
Many additional 510(k)-approved devices have gone on to harm thousands of patients. These products include metal-on-metal hip replacements, transvaginal mesh, and power morcellators, among others.
FDA Commissioner Scott Gottlieb announced the planned 510(k) overhaul on Monday. However, he denied that the Associated Press investigation had driven their decision.
Among other things, Gottlieb noted that predicate devices are sometimes decades old. He wants to encourage device makers o utilize predicates that are no more than 10-years-old.
“What we want to do is constantly push the market toward incorporating better technology and better capabilities by advancing the predicates and always looking forward so the … predicates the device companies are using as the basis of their approvals are constantly incorporating newer and better technology to make the devices better and safer,” the FDA Commission said during an interview with CNBC.
To accomplish this, the FDA might publish a list of medical devices approved on the basis of old predicates. Additionally, the agency is working on proposals to “sunset” certain older predicates and actively promote more modern devices.
Dr. David Challoner, an expert on the FDA’s review system, told the Associated Press that the overhaul would likely improve safety. However, he worried that industry pressure would ultimately stymie the initiative.
“If the device industry comes back at this full bore with their lobbying efforts, this could all die a slow and painful death,” he said.
Unfortunately, industry group AdvaMed has already voiced strong concerns regarding the FDA’s predicate modernization plans.
“It is our hope that through the regulatory review, the agency 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 group’s CEO said in a statement issued on Wednesday.