Washington (December 16, 2013) – Today, Senator Edward J. Markey (D-Mass.) applauded the Food and Drug Administration (FDA) announcement of improvements to several public medical device databases, reiterating his call to close the current loophole in federal law that allows defective devices to enter the market and jeopardize patient safety. In August 2012, then-Rep. Markey and Senator Jeff Merkley (D-Ore.) sent a letter to the FDA calling on the agency to reform the medical devices databases. The improvements announced today to the Medical Device Recalls, 510(k), and Premarket Approval (PMA) databases will provide device manufacturers, the public, and medical professionals with better information about devices recalled for serious design flaws and to help avoid future patient injuries. The federal loophole in the 510(k) device approval process – named after its section in the law –requires the FDA to clear medical devices that demonstrate their similarity to an earlier model, even if that previous model was recalled for a major safety defect.
“These database improvements will help decrease the dangers and increase the awareness of medical devices that may be made based on flawed models,” said Senator Markey, a member of the Commerce, Science and Transportation Committee. “Patients should not be put at risk by devices that are allowed to be sold only by proving their similarity to a defective product. These database reforms are a critical first step, but we still need to close the loophole in the device approval process that puts patients at serious risk of debilitating injury by ensuring that devices do not mimic the mistakes made by other products.”
The 510(k) loophole has enabled a number of defective products to enter the market and cause serious harm, and in some cases even death. The updates to the 510 (k) database will help identify if a medical device was subject to a recall due to a design flaw, as well as if the medical device was cleared by the FDA on the basis of a previous design that was recalled for a serious flaw. The other database improvements will help ensure the public has access to safety information on marketed medical devices, including the recall status of a device and the root cause of the recall as determined by the FDA.
In February 2012, then-Rep. Markey introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). The legislation aimed to close the major loophole in the 510(k) device approval process by allowing FDA to reject an application for a new device if it was modeled after an earlier product that was pulled from the market for causing serious harm to patients.