The Institute of Medicine (IOM), an influential body that advises the federal government on science policy, proposed last week that the FDA scrap the process it uses to clear many medical devices for use because the current method could not ensure the safety and effectiveness of the medical devices. According to the 280-page IOM report, the FDA should require more extensive testing of thousands of “moderate-risk devices” — from wheelchairs to artificial hips — that come to market with little study because manufacturers can argue that the devices are “substantially equivalent” to products already in use.
Known as the 510(k) clearance, or premarket notification, the process provides a more expedient way for the FDA to evaluate moderate-risk Class II devices than the premarket approval (PMA) that high-risk Class III devices must undergo. Unlike the PMA process, which requires manufacturers to submit results of safety and efficacy tests, the 510(k) clearance generally relies on “substantial equivalence” — 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.
The report was issued just as device makers have been urging the FDA to streamline the approvals system. A group of manufacturers had also been campaigning to undermine the report before it was published, saying the 12-member panel of physicians, lawyers and policy experts did not represent all points of view.
The IOM committee of 12 experts faulted the 510(k) process because it potentially allowed a device to slowly evolve from its “substantially equivalent” predecessor device without ever getting its own assessment for safety and effectiveness. Compounding this potential danger is the fact that many of the older devices used as the basis for the comparison themselves were never fully tested.
Surprisingly, although the FDA’s Center for Devices and Radiological Health (CDRH) had asked for the IOM’s advice on the matter, the agency’s initial response downplayed the central finding of the panel. “FDA believes that the [current] process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” said Jeffrey Shuren, M.D., director of the CDRH.
Shuren was not alone in rejecting the IOM’s call to abandon the 510(k) process. In that regard, he was joined by the leading industry advocate – Stephen Ubl, president, Advanced Medical Technology Association, a group that has ironically been previously critical of how the FDA manages the 510(k) program. “Numerous academic studies have shown that the 510(k) process is overwhelmingly safe,” said Ubl in a news release. “Yet the report recommends entirely scrapping this proven process with a vague new plan that contains no useful guidance.”
The FDA, however, did open a docket to accept public comments on IOM report.
The IOM panel was clear in stating that it “does not believe . . . there is a public health crisis related to unsafe or ineffective medical devices.” The panel noted that many devices that have not been “systematically reviewed” are in use offers some assurance they are safe. Some of the IOM’s recommendations, such as designing a new regulatory framework for Class II (moderate risk) devices, may require congressional actions. The report did not offer specifics on what a replacement for the 510(k) process would entail.
A new framework to make sure these devices are safe and effective without stifling innovation that could improve patient health would take some time to test and implement. It will be interesting in the aftermath of the IOM report whether a consensus framework that would satisfy both the business demands of medical device manufacturers’ bottom line to have products to market as soon as possible and keep the public satisfied as to the regulatory function of the FDA could be devised.
The FDA is not known for expendiency in the milleu of medical devices. “After 35 years, the FDA has not completed the task of calling for PMAs for or reclassifying preamendment Class III device types,” the IOM panel said. “Congress in 1990 directed the FDA to complete this task in a timely manner.”