Medical Device Regulator Wants More Authority to Ban Dangerous Medical Devices

The Food and Drug Administration’s top medical device regulator is supporting federal legislation that would make it easier for the FDA to step in and ban dangerous medical devices that fail and harm unwitting patients. The statement of support comes in the wake of the recent spate of artificial hip devices and the vaginal mesh device that have failed and are the subject of numerous medical device lawsuits.
According to Bloomberg News, “The debate centers on the agency’s 510(k) program, the system used to clear 90 percent of medical products in the U.S. each year. The process can allow devices on the market without human testing if the FDA deems them “substantially equivalent” to previously approved versions, known as predicates.”
This loophole has allowed many medical devices to be used without the proper safety protocols and has led to voluntary recalls and lawsuits. If the FDA is allowed to reject such devices and close the loophole created by the 510(k) process, medical devices would take longer to reach the marketplace but would ultimately be safer and less prone to recalls. Safety advocates have called for such action for years but have been stymied in their efforts by the medical device industry and their lobbyists who argue that the 510(k) process allows life-saving medical devices to reach the market quicker and at a substantially lower cost. Of course, those who advocate such an approach never mention the fact that the 510(k) process boosts device company profits often at the expense of consumer safety.
That’s why Jeffrey Shuren,director of the FDA’s Center for Devices and Radiological Health, is supporting legislation sponsored by House Democrats that would essentially close this medical device loophole. “It’s good for patients and it’s good for companies and it assures that if there’s a problem with the new device, it gets addressed before it goes to market,” Shuren said by telephone. “The challenge now is if there’s a problem, it can get replicated” through future generations of devices.”
Bloomberg News reports, “The legislation, HR3847, was introduced Feb. 1 by four Democrats led by Representative Edward Markey of Massachusetts. Besides giving the FDA more power to reject devices, it would require manufacturers to submit information about recalls of predicates used in an application. The agency also would be required to review previously cleared products to see if any have safety issues in their “device lineage.”