U.S. regulators should ensure that high-risk medical devices undergo a tougher review process by the FDA before allowed to enter the market, according to a report from the Government Accountability Office (GAO).
The FDA classifies types of devices depending mainly on the amount of risk they pose to the patient or the user, according to the report. The least risky types of devices, such as tongue depressors and elastic bandages, are class I, while the riskiest, such as pacemakers and replacement heart valves, are class III. Devices such as mercury thermometers and blood pressure cuffs fall in the middle, in class II.
The GAO report sad that the FDA had cleared more than 200 high-risk devices, known as "class III," to go through a less stringent review process that was intended for simpler products, USA Today reported.
Unless exempt under FDA regulations, GAO said that medical devices should go through one of two types of FDA reviews before legally marketed in the United States. The 510(k) review process is typically quicker and less expensive than the more-stringent premarket approval process, which requires manufacturers to conduct trials in people to demonstrate safety and effectiveness, the report said.
The FDA should "expeditiously" issue regulations that would require the toughest level of review for all products deemed high-risk, according to the report, whose findings were based on devices reviewed between fiscal years 2003 and 2007.
"GAO's investigation confirms my concerns that the approval process for medical devices is woefully inadequate. For years, Congress has required high-risk medical devices to undergo stringent pre-market review, but GAO's findings show that is simply not happening in every case," said Rep. Frank Pallone, D-N.J., who chairs the health subcommittee of the House of Representatives Energy and Commerce Committee.
The Department of Health and Human Services (HHS) agreed with the GAO recommendations but did not say when it would address the issue, reported Reuters.