The Safety Debate

How safe and effective are new medical devices? With the current 510(k) system, there’s no telling, says government report

Manufacturers are objecting to an Institute of Medicine report calling for the Food and Drug Administration to scrap its 510(k) clearance process for moderate-risk Class II devices. And the FDA doesn’t care for it either.

The IOM report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years,” had been commissioned by the FDA in September 2009. Then, the FDA had asked the IOM to study the 510(k) process and answer two questions:

  • Does the current 510(k) process protect patients optimally and promote innovation in support of public health?
  • If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally?

The IOM came back with its answer: The 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices, and cannot be transformed into one.

Rather, the FDA should develop a new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices throughout the duration of their use. The rub, of course, is that the FDA should do so without throwing too many roadblocks in the path of medical innovation.

‘Substantial equivalence’
The 510(k) clearance process was designed 35 years ago to provide a more expedient way to evaluate moderate-risk Class II devices than the premarket approval (PMA) for high-risk Class III devices. Unlike the PMA process, which requires manufacturers to submit results of safety and efficacy tests, the 510(k) clearance generally relies on “substantial equivalence,” that is, determining if new devices are sufficiently similar to comparable products that have been previously cleared or were on the market prior to 1975 when the 510(k) process was first put in place by legislative action. A flaw in the current process is that the majority of the devices used as the basis for comparison were never reviewed for safety or effectiveness, according to IOM.

The IOM recommended that FDA explore whether a modified version of its de novo process could replace the 510(k) process. The de novo process reduces the amount of information manufacturers must supply for devices deemed to be of low or moderate risk, but that have no predicate devices against which to be compared. Changes would be necessary to fix problems that make the de novo process time-consuming and difficult to navigate before FDA initiates a pilot program.

Postmarket surveillance
No premarket regulatory system can guarantee that all medical devices will be completely safe and effective in the field, the committee noted. Because of the differences between devices and drugs, it would be impractical for all devices to undergo the same sort of premarket testing that drugs must go through. For that reason, a robust postmarket surveillance of these products is essential, the report says.

However, the committee found substantial weaknesses in current postmarket oversight of devices. The FDA faces limitations on its authority to address problems with products on the market, and the agency should analyze what barriers hamper the efficient and effective use of its regulatory tools, the report says. If necessary, Congress should pass legislation to remove barriers to FDA’s use of postmarket regulatory authority. The agency also should develop and implement a comprehensive strategy to collect, analyze, and act on information about devices’ performance after clearance.

FDA should promptly complete its task of determining how to handle 26 device types classified as “high risk” that are allowed to reach market through the 510(k) process. FDA can either reclassify these types into a lower risk category if warranted, or require them to go through the PMA process. Devices considered substantially equivalent to products in these 26 categories continue to be cleared for the market through the 510(k) process.

More to come
“FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement.
No doubt those proposals will be forthcoming.

Throwing their support behind the IOM’s conclusions were Gregory D. Curfman, M.D., executive editor of the New England Journal of Medicine, and Rita F. Redberg, M.D., editor of the Archives of Internal Medicine. In the Aug. 10 New England Journal of Medicine, they wrote, “We believe that the IOM report is insightful, judicious, sensible, and long overdue. The 510(k) clearance process was established 35 years ago, and although it may have been a reasonable approach then, it surely is not today. We support the IOM committee’s recommendation that the 510(k) process be replaced with an evaluation of safety and effectiveness. It is important to maintain and encourage innovation in medical devices. But true innovation requires that safety and effectiveness be proven by scientific study in clinical trials.

The authors recommended that the FDA take these steps immediately:

  • Stop the use of 510(k) clearance for Class III devices. “A substantial equivalence standard for clearance of such complex devices is untenable.”
  • Eliminate the use of multiple predicates in 510(k) clearance. “Now a device may be cleared if it is found to be substantially equivalent to an existing device that was cleared, in turn, by being found substantially equivalent to another device, and so on,” they wrote. “This tenuous process should be discontinued.”
  • Put into place a formal system of postmarketing surveillance for medical devices. “Strong, mandatory, and transparent postmarketing data, in registries, allow rapid identification of serious problems that may emerge after approval. Careful tracking of every patient with a high-risk device is a crucial step for ensuring patient safety and avoiding nightmare scenarios.”

Meanwhile, manufacturers took exception to much of what the IOM said. “Numerous academic studies have shown that the 510(k) process is overwhelmingly safe,” Stephen Ubl, president and CEO of the Advance Medical Technology Association (AdvaMed), said in a statement. “The IOM committee itself acknowledges that there is no evidence that the 510(k) process is failing to assure safety and effectiveness. Yet the report recommends entirely scrapping this proven process with a vague new plan that contains no useful guidance.”

“MDMA will continue to closely examine this report, though we completely disagree that the 510(k) pathway is ‘flawed’ and that the FDA needs to eliminate it,” Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said. “We remain concerned about reform efforts that would create additional uncertainties and slow patient access to medical therapies.”

To read the full IOM report, go to