IOM urges new device-clearance process

Updated with comment from a conference call

The expedited 510(k) process, in which some medical devices are cleared by the Food and Drug Administration, is flawed and Congress should enact legislation for a new regulatory framework to be developed in its place, according to a highly anticipated report from the Institute of Medicine.

The IOM committee recommended that Congress pass legislation once the FDA gathers needed information to design the new system.

“Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA's finite resources would be better invested in developing an integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle,” the authors wrote.

The FDA, as well as the Advanced Medical Technology Association, which represents device makers, and the Medical Imaging and Technology Alliance said in separate statements that they do not support the IOM's recommendation to scrap the 510(k) process.

“We realize we are suggesting a paradigm shift,” said David Challoner, chair of the committee, in a webcast.

Moderate-risk devices, which make up 43% of devices on the market, can be cleared by the 510(k) process if they are “substantially equivalent” to another device already on the market, or to one cleared before 1976 when the Medical Device Amendments was enacted. Moderate-risk and low-risk devices cleared before then were not subject to an FDA evaluation of safety and effectiveness.

The report's committee concluded that a 510(k) clearance does not show that a comparable device is safe or effective because the majority of devices used as the basis for comparison were not reviewed for safety or effectiveness.

“The committee finds that the current 510(k) process is flawed based on its legislative foundation,” wrote the authors.

The committee also had strong recommendations for the FDA. It said the agency should develop a strategy to collect and analyze medical device performance after clearance and tap into post-market enforcement powers, including seizing or banning a device when necessary.

Congress should pass legislation that would remove barriers to FDA's post-market authority to overcome what FDA told the committee are “limitations on its authority to address problems with products on the market.”

“The committee found that available information on post-market performance of devices does not provide sufficient information about potential harm or lack of effectiveness to be a useful source of data on the safety and effectiveness of marketed devices,” according to the report. “The committee does not believe, however, that there is a public-health crisis related to unsafe or ineffective medical devices.”

The 510(k) process has been an ongoing issue in Washington, with policymakers and patient groups raising concerns about safety, while industry argues that the FDA's approval process has become increasingly unpredictable.

Challoner said that developing a new system to replace the 510(k) process will create a “more reliable environment” for device makers, venture capitalist, and other funders – many of whom have complained about the unpredictability of FDA's clearance process in recent years.

The report was commissioned by the FDA in 2009. The agency said it will accept public comments on the report.