Report: FDA should scrap 510(k) process

SAN JOSE, Calif. – Industry groups are blasting a much-anticipated report from the Institute of Medicine (IoM) that calls for scrapping the current regulatory process used by the vast majority of medical devices.

A panel of 13 experts convened by the IoM said he U.S. Food and Drug Administration should replace the 35-year-old 510(k) process used to approve moderate-risk medical devices. It called for creating an entirely new process but only provided rough guidelines for what that process might be.

"It's not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help," said David Challoner, emeritus vice president for health affairs at the University of Florida, Gainesville who chaired the IoM panel.

"While current information is not adequate to immediately start designing a new framework, we believe the agency can get the necessary data and establish a new process within a reasonable time frame," he said.

The bold conclusion stunned many in the medical electronics sector. Two top industry lobbying groups were quick to criticize the recommendations, saying they added too much uncertainty to a process that was imperfect but basically sound.

"The report’s conclusions do not deserve serious consideration from the Congress or the Administration," said Stephen J. Ubl, president of the Advanced Medical Technology Association (AdvaMed) which represents many top U.S. medtech companies.

The report "proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure--a disservice to patients and the public health," he said in a press statement.

Ubl said the FDA's plan released in January to take more than 20 steps to improve the 510(k) process was a better step forward. "Other targeted reforms may also be appropriate," he added.

Mark Leahey, president of MDMA which represents many small and medium-sized medical device companies, issued a more moderate response. "We remain concerned about efforts to overhaul a regulatory pathway that would create additional uncertainties and slow patient access to medical therapies," he said.

Prior to the release of the report, one leading academic criticized what he characterized as the relatively opaque process of the IoM committee and its lack of representation of some stakeholders.

For its part, the IoM panel said "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.

"FDA's finite resources would be better invested in developing a new framework that uses both premarket clearance and improved post-market surveillance of device performance," it added.

The 510(k) process lets companies get approval for devices characterized as moderate risks that are "substantially equivalent" to devices that have already been approved by the FDA.

"Substantial equivalence cannot assure that devices reaching the market are safe and effective," the panel said. "The majority of the devices used as the basis for comparison were never reviewed for safety or effectiveness," it added.