“The committee found that the 510(k) program lacks the statutory basis to make it a reliable premarket screen for safety and effectiveness of Class II medical devices,” the IOM committee wrote in its report.
"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 committee chair David Challoner, emeritus vice president for health affairs, University of Florida, Gainesville, in a press release about the report.
"The 510(k) process cannot achieve its stated goals – to promote innovation and make safe, effective devices available to patients in a timely manner – because they are fundamentally at odds with the statutes that govern how FDA must implement the process. 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," said Challoner.
The new framework should use “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 committee also noted that while it believes the current program is ineffective, it does not believe there is a public health crisis related to unsafe or ineffective medical devices.
“We appreciate the IOM’s report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a press release responding to the IOM’s report. However, he continued, “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.”
The FDA commissioned the 510(k) report from the IOM in 2009, but it is not required to abide by the IOM’s recommendations. It plans, though, to seek public comment on the IOM’s recommendations and dedicate itself to “an aggressive action plan designed to improve predictability, consistency, and transparency under the existing statutory framework, not only to the 510(k) process but to our device review programs in general.”