WASHINGTON (Reuters) - U.S. regulators should make sure high-risk medical devices undergo the agency’s toughest review process before they are allowed on the market, a congressional watchdog report said on Thursday.
The Food and Drug Administration oversees devices ranging from simple bandages and tongue depressors to the most complex such as pacemakers and heart-valve replacements. Each is classified based on the level of risk to patients.
The General Accountability Office said in a report 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.
The FDA should “expeditiously” issue regulations that would require the toughest level of review for all products deemed high-risk, the report said.
A Democratic lawmaker said he would hold hearings on the FDA’s device review process and, if needed, develop legislation to protect patients.
“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 New Jersey Rep. Frank Pallone, who chairs the health subcommittee of the House of Representatives Energy and Commerce Committee.
The GAO findings were based on devices reviewed between fiscal years 2003 and 2007.
During that time, 228 high-risk devices were approved after the less-stringent review, the GAO said.
The Department of Health and Human Services, the parent agency of the FDA, agreed with the GAO recommendations but did not say when it would address the issue, the report said.
“Given that more than three decades have passed since Congress envisioned that all class III devices would eventually be required to undergo pre-market review through the more stringent (approval) process, it is imperative that FDA take immediate steps,” the GAO said.
FDA spokeswoman Karen Riley said “we’re considering the legal and procedural options to accomplish the objective.”
Diana Zuckerman, president of the National Research Center for Women & Families, said the report showed “the FDA continues to approve products that are not adequately scrutinized to make sure they are safe.”
Device companies agree with the report’s finding that the FDA should finish reclassifying a group of older devices to determine which ones need a stronger review, said Susan Alpert, senior vice president and chief regulatory officer for Medtronic Inc.
“Patients should not be concerned” about the safety of any devices that went through the less-stringent process, which requires evidence a product is “substantially equivalent” to one already on the market, said Alpert, who spoke on behalf of industry group AdvaMed.
“There is a significant amount of work that is done” to meet that criteria and “a lot of experience with these technologies,” said Alpert, a former director of the FDA’s office of device evaluation.
Editing by Richard Chang, Phil Berlowitz