August 17, 2012 — Two lawmakers are asking the U.S. Food and Drug Administration (FDA) to close the 510(k) loophole, which allows for the fast-track approval of new medical devices without requiring safety studies, so long as the manufacturers claim the device is “substantially equivalent” to an existing device. Rep. Edward Markey (D-MA) and Sen. Jeff Merkley (D-OR) said the 510(k) system “opens the door for defective devices to make their way on to the market and jeopardize public safety.”
According to a letter sent by tthe lawmakers, one of the biggest problems with the 510(k) system is that it virtually guarantees the FDA will approve new products without clinical trial data — even if the new product has the same design flaws as the previous product. They 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.”
The congressmen are asking to expand the FDA’s authority to allow it to reject a device if it is designed with the same flaws that make it highly likely to malfunction. They are also asking for an improved system for providing the public with information about devices that are recalled for serious design flaws.
Greater transparency could be accomplished if the FDA updated its database to include information about whether the device itself is the subject of a recall, and whether its approval was based on a device that was recalled.
The congressmen said, “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.”
One example of this is vaginal mesh, which has been linked to thousands of severe injuries — including perforation of internal organs, erosion into the vagina, scarring, nerve damage, and permanent decreased quality of life. Surprisingly, many vaginal mesh devices were approved under the 510(k) system, based on their “similarity” to a device that was already recalled in 1999 due to safety concerns (Boston Scientific’s ProteGen). Despite the known safety hazards, the 510(k) loophole allowed new devices on the market with the same design flaw that subsequently injured thousands of women.
One of the few pieces of legislation to be approved by Congress this year was an overhaul of the FDA approval system, which met little resistance and had broad bipartisan support. The legislation imposed new user fees on drug and medical device companies in exchange for expedited approval of new products. Legislators proposed adding language that would close the 510(k) loophole, but lobbyists for drug and medical device companies successfully eliminated the provision.
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