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August 16, 2012

FDA Asked to Crack Down on Approving Recalled Devices for Resale

First it was hip implants. Then, heart stents, followed by brain stents. And now, two members of Congress are saying enough is enough, and that it’s time for Congress to allow the FDA to reject an application for a new device if it is modeled after an earlier product that was pulled from the market after causing harm.

Legislation introduced in February, H.R. 3847, asks that lawmakers finally stop pushing through medical devices for approval by requiring that even revisions of failed products must go through the process again, according to a story by Eric Wicklund.

Seems to make sense. But powerful device manufacturers have fought successfully for years to prevent just that. The bill is still pending in the House of Representatives.

The shocking reality is that more than 90 percent of medical devices do not require clinical testing before the FDA clears them for sale. Instead, the FDA clears these devices through its fast track 510(k) process based on whether they are "substantially equivalent" to devices that are already on the market.

Wicklund reported that even without the legislation enacted, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) asked FDA to “update the 510(k) database to clearly indicate devices that have been recalled for design flaws that could affect safety or effectiveness, update the database within 30 days after completing a review of a manufacturer’s root-cause analysis that concludes a flaw triggering a recall was serious, include in the database clearly marked past recalls for serious design flaws that could affect safety and effectiveness, and revise the 510(k) Premarket Notification database to notify the public that a certain product repeats the same design flaw that caused a predicate’s recall.”

A story last year by Rob Stein noted FDA’s laxness in protecting the public from faulty devices. 

He revealed that a study of the 113 devices that FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients' lives, a whopping 71 percent had been approved without undergoing testing in people.

That’s because current rules allow manufacturers to return retooled devices to the market without FDA clearance. 

So who’s watching out for the public? That’s what Markey and Merkey are setting out to do.

Edited by Braden Becker
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