Representative Edward J. Markey (D-MA) and Senator Jeff Merkley (D-OR) sent a letter to FDA calling on the agency to streamline federal databases that provide information to the public on the safety of medical devices. However, these devices may not have undergone clinical trials in humans before being sold on the market.
In the absence of legislation that would close the current loophole in federal law that allows defective devices to enter the market, the lawmakers are urging reforms be made immediately to the FDA’s main medical device databases. The updates would provide device manufacturers, the public, and medical professionals better information about devices recalled for serious design flaws and help avoid future injuries.
Last February, a group of Representatives introduced the “Safety of Untested and New Devices Act of 2012” or referred to as the “SOUND Devices Act”. The legislation would 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. The legislation is pending in the House of Representatives.
The federal loophole in the 510(k) device approval process 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.
This loophole has enabled a number of defective products, such as bladder mesh implants, to enter the market and cause serious harm and in some cases even death. The updates to the 510(k) databases requested by the lawmakers would reflect if a medical device was subject to a recall due to a design flaw and if the medical device was cleared by FDA based on a previous design recalled for a serious flaw.
Go to http://markey.house.gov/document/2012/letter-fda-501k-database to view a copy of the letter sent to FDA.