Consumer groups urge FDA to rescind 510(k) clearance for Aptus endostapler

February 29, 2012 by MassDevice staff

A group of consumer advocates demanded that the FDA heighten testing requirements for certain medical devices, taking exception to the agency's 510(k) clearance of Aptus Endosystems Inc.'s HeliFX endostapling system.

In a letter to FDA commissioner Dr. Margaret Hamburg, a coalition of 12 patient safety groups expressed their concern that the de novo pathway, intended for moderate-risk products with no substantial equivalents already on the market, was inappropriately used for higher-risk products – like the HeliFX – that should have gone though the more rigorous pre-market approval process.

Although not at odds with the de novo system itself, the troup argued that the HeliFX system, categorized as a Class III device and designed to fix leaks and migration in implanted endografts, circumvented the more appropriate and stringent PMA pathway by claiming to be something it isn't.

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"FDA has responded to the Institute of Medicine's recommendation by starting to beef up the de novo process, but instead of selecting a moderate-risk device, as the law requires, the FDA inappropriately used the de novo review process for a device that is obviously intended to save lives," Dr. Diana Zuckerman, of the National Research Center for Women & Families, one of the signers of the letter, said in prepared remarks. "To get around the law, the FDA is claiming that the product is not life-saving and therefore does not need to be tested by rigorous clinical trials and inspections, as is required for life-saving devices."

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