Contact: Jennifer Fuson
202-965-3500, ext. 8369
Washington, DC—The Food and Drug Administration (FDA) should strengthen post-approval requirements for 510(k) medical devices and increase scrutiny of complex devices – but not give complete immunity to manufacturers when their products are defective, according to comments submitted today by the American Association for Justice (AAJ).
The comments are in response to recommendations from the FDA's 510(k) Working Group. The 510(k) process is used to approve medical devices that are substantially equivalent to medical devices already in the marketplace.
In its submitted comments, AAJ supports the 510(k) Working Group’s recommendations that will make the process safer and more efficient, but opposes any effort to limit the rights of patients to hold manufacturers accountable for defective devices.
“Device manufacturers should have every incentive to ensure their products are safe for patients,” said AAJ President Gibson Vance. “Giving complete immunity to negligent manufacturers of 510(k) devices is not only contrary to current law, but will leave patients injured by defective devices with absolutely no recourse.”
Currently, the FDA has not finalized regulations that would allow for rescission of a 510(k) clearance, although the agency proposed these regulations in 2001. AAJ comments list instances in which it would be appropriate to rescind a 510(k) clearance, including new safety data or information regarding adverse events linked to the device, fraud in the clearance process and problems with the underlying clinical data that was used to clear the device.
Because of a 2007 U.S. Supreme Court ruling in Riegel v. Medtronic, thousands of patients have no legal recourse when they have been injured by certain faulty medical devices. Congress has introduced the Medical Device Safety Act (S. 540 / H.R. 1346) to restore the rights of medical device patients to seek remedy in court as Congress had intended when they passed legislation on medical device safety in 1976.
AAJ's comments can be found here.