SAN JOSE, Calif. – U.S. regulators were quick to reject the conclusion of a report saying it should scrap its most widely used process for approving medical devices. They also launched a public comment period on the 227-page report whose conclusions are likely to be widely debated for some time.
Members of the Institute of Medicine panel that wrote the report effectively started the discussion today. In a conference call, they explained their recommendation to replace the FDA's 510(k) program that reviews about 4,000 medical devices a year categorized as Class II or moderate risk.
The panel rejected the 510(k) approach of approving products by showing they are "substantially equivalent" to existing ones in the market. They said most products that have been approved under the 35-year-old program are generally safe and effective, but the approach was not sustainable.
In its place, the panel called for a new framework that more directly investigates whether devices are safe and effective before they are put on the market and monitors products throughout their life. They provided no detailed recommendations for a new approach, but suggested a starting point could be a revamped version of the so-called de novo process, an existing path for novel, moderate-risk devices.
"The 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," said Jeffrey Shuren, director of the FDA's medical devices unit, speaking in a press statement.
The FDA will hold a public meeting "in the coming weeks" to discuss the non-binding recommendations of the report. It will take online and written comments on the IoM report through September 30.
Creating a new regulatory structure for moderate-risk devices may require congressional action, the agency said. In January, the FDA laid out a set of more than 20 steps it started taking this year to revise the existing 510(k) process.
Two industry groups were quick to reject the findings of the report. Like the FDA, they called for revising the existing 510(k) process rather than scrapping it to start work on a new framework.
The medical electronics sector has long called for reforms of all the FDA's regulatory processes, including the Pre-Market Approval (PMA) process used for high-risk devices such as pacemakers. All the existing processes are too slow and complex, a problem the IoM report doesn't directly address, some argued.
"To say throw out the 510(k) system, and not say what to replace it with doesn’t help anyone," said Ralph Hall, a University of Minnesota law professor and medical device expert who criticized the IoM panel's approach and makeup prior to the release of the report.
"I think a lot of stakeholders were expecting more specific recommendations than what the committee came up with," said Hall who also advises medical device companies and has his own implant startup. "They didn’t have specific data about actual problems, so this was more of a theoretical concern," he said.
"If the remedy is to move to a PMA-like process which is the most rigorous at the FDA--that’s a great concern," said Paul Citron, a retired executive at Medtronic that reviewed an early draft of the report but had not yet read the final version.
"The FDA's own data shows U.S. citizens receive life-saving technologies years after the identical technologies are available in Europe and elsewhere, and that’s not a good thing for patients or industry," said Citron who served as vice president of technology policy at Medtronic.