Lawmakers Want to End 510(k) Medical Device LoopholeAugust 17, 2012 — Two U.S. lawmakers are calling on the U.S. Food and Drug Administration (FDA) to make changes to the 510(k) medical device approval system. This loophole allows manufacturers of new devices to gain approval without conducting safety studies, if they claim their product is similar to another device already on the market. Sen. Jeff Merkley (D-OR) and Rep. Edward Markey (D-MA) sent a letter asking the FDA to close the loophole, because it “opens the door for defective devices to make their way on to the market and jeopardize public safety.”


The lawmakers’ biggest concern was that the 510(k) process forces the FDA to fast-track the approval of new devices without reviewing clinical safety data, even if the new device has known design flaws that present a public safety hazard. The lawmakers said, “Current law requires FDA to clear a device shown to be substantially equivalent to a predicate, even in cases where the new product contains the same flaw as an earlier model that had to be recalled by the manufacturer due to a fundamental design flaw.”

In a letter sent to Jeffrey Shuren, head of the FDA’s medical device approval department, the lawmakers made two major requests: 1) Expand the FDA’s authority so they can reject a 510(k) application if the new device is likely to malfunction due to known design flaws in previous devices. 2) Improve the transparency of the 510(k) system by providing information when devices are recalled for safety concerns, or when their approval is based on a product with safety problems.

“If the new device repeats the same design flaw that caused the predicate to be recalled, the public should be aware that a potentially dangerous device is being sold in the market,” they wrote.

The lawmakers cited the case of hip implants and vaginal mesh — just two of many medical devices approved under the FDA’s 510(k) system that have been linked to tens of thousands of severe, life-threatening injuries or deaths.

Vaginal mesh has been linked to severe scarring, perforation of internal organs, disfigurement, life-threatening infection, chronic pain, nerve damage, and other severe complications. Thousands of women have been permanently injured by these devices. Many women are surprised and angry to learn that many vaginal meshes were approved under the 510(k) system — and their approval was based on “similarity” to Boston Scientific’s ProteGen, a device that was recalled in 1999 after causing hundreds of severe injuries.

Lawmakers have previously attempted to close the 510(k) loophole, unsuccessfully. One of the only pieces of legislation to pass through the 2012 Congress quickly and with bipartisan support was a bill that overhauled the FDA’s approval process for drugs and medical devices. By imposing new user fees on drug and medical device companies, the FDA agreed to expedite the approval process.

In the original drafts, lawmakers proposed closing the 510(k) loophole, or at least making changes to the system. Lobbyists for the drug and medical device industry successfully blocked the changes, and the 510(k) system passed Congress intact.

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