update RLG Hopes Congress Passes Legislation Permitting FDA to Refuse to Approve Medical Devices Substantially Similar to Products Already Pulled From Market for Safety Reasons

The Rottenstein Law Group hopes Congress adopts the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act), which would prevent medical devices from being approved for sale by the FDA based solely on their similarity to devices that have been pulled from the market.

Introduced by a group of by Democratic lawmakers led by Representative Edward Markey of Massachusetts, the SOUND Devices Act (HR3847) seeks to close “a significant loophole” in the FDA process used to clear “approximately 90 recent of the medical devices authorized for commercial sale,” according to Rep. Markey’s website.

The FDA-clearance system that the SOUND Devices Act seeks to correct is known as the 510(k) process, and it allows manufacturers to obtain FDA approval for a medical device without subjecting that device to tests on humans. To qualify for 510(k) approval, a device need only be “substantially similar” to an apparatus that is already on the market, known as a “predicate.” A device approved pursuant to the 510(k) process can then be used as a predicate itself when manufacturers later seek FDA approval for devices substantially similar to it.

If enacted, Rep. Markey’s bill would, among other things, give the FDA the ability to reject a device application based on a predicate that has been recalled or is in the process of being removed from the market for major safety problems. It would also require companies to inform the FDA if any products in their new device’s “predicate lineage” have caused serious harm.

The SOUND Devices Act is specifically intended to help decrease the likelihood of consumers ever again experiencing injuries similar to “the devastating effects that resulted from defective bladder mesh implants,” according to Rep. Markey’s website. Indeed, many of the vaginal mesh products that allegedly caused many consumers irreparable harm were granted FDA clearance based on their similarity to devices that were once cleared for sale, but have since been removed from the market because it became clear they are dangerous. Johnson & Johnson, for example, is “battling lawsuits” over a vaginal mesh product that got FDA approval based on its similarity to a device that was “pulled from the market more than a decade ago for safety reasons,” according to a Bloomberg article that ran on Oct. 27, 2011.

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