Rep. Markey steps up blitz on 510(k) loophole

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Democratic Congressman Edward J. Markey of Massachusetts is pounding the drum on the SOUND Devices Act, which he and three fellow House Democrats introduced Jan. 31 to tighten the FDA’s 510(k) approval process.

In a report posted online March 22, “ Defective Devices, Destroyed Lives,” Markey’s office called out the “federal loophole” that calls for the FDA to clear medical devices that demonstrate sufficient similarity to earlier models “even in cases where the new product repeats the identical flaws as an earlier model—the predicate—that was pulled from the shelves. Device manufacturers can also continue using a voluntarily recalled device as a predicate, even if the recall was triggered by a defect causing serious injury or death.”

The report includes testimonies from patient advocates as well as patients harmed by 510(k)-cleared devices. It follows on the heels of the January bill, HR 3847, the Safety Of Untested and New Devices Act of 2012, co-sponsored by Henry A. Waxman of California, Jan Schakowsky of Illinois and Rosa DeLauro of Connecticut. If passed, the bill will allow the FDA to reject device applications based on predicates affected by recalls or alerts.

The report noted that the SOUND Devices Act requires manufacturers to explain to FDA how their new device avoids known defects in its predicate while also providing FDA with “clear authority to reject clearance of a medical device if it repeats flaws found in a previously recalled device. Now is the time to close this lethal loophole.”

Markey serves on two healthcare-related Congressional caucuses, the Bipartisan Caucus on Alzheimer’s Disease, which he co-chairs, and the Bipartisan Caucus on Cystic Fibrosis.