The IOM panel also called on the FDA to take action on 26 device types that are classified as "high risk," but eligible to be cleared for the market under the 510(k) process. The FDA should either reclassify these devices into a lower-risk category or require them to go through the more rigorous premarket approval process, the IOM panel said. The FDA is already looking at this problem and plans to complete its review and reclassification of these device types by the end of 2012.
The FDA asked the IOM to review its 510(k) clearance process in September 2009. In recent years, there have been reports of problems with a number of devices cleared through the process. At the same time, the device industry has complained the process is too burdensome and slows the pace of medical innovation. The IOM panel was charged with determining whether the 510(k) process protects patients and promotes innovation and what changes could improve the process.
Even before the report was released, the IOM panel and its process were under fire from critics. In June, the Washington Legal Foundation called on the FDA to disregard any advice from the IOM on the 510(k) pathway. The group filed a citizen petition arguing that the IOM panel was not "fairly balanced" because it did not include individuals with experience in areas of importance to the committee’s charge, such as product developers who are familiar with the FDA clearance process or patients who would benefit from the medical devices. Achieving balance on the committee is critical, even if it means appointing individuals with conflicts of interest, the group wrote. The IOM said the 12 members of the 510(k) expert panel had a range of relevant expertise related to the development and regulation of medical devices, postmarket surveillance, health sciences policy, consumer protection, and FDA processes.