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.