FDA 510(k) Loophole To be Closed? Don't Hold Your Breath | Levin Papantonio Rafferty - Personal Injury Lawyers

FDA 510(k) Loophole To be Closed? Don't Hold Your Breath

It's what allowed Johnson & Johnson (among others) to push medical products on to the market that had not been properly tested – and that, in all probability, these companies knew to be risky to patients.

It's called the “510(k)” process, a topic I've written a number of posts about. This process is discussed in detail here, but  for those who are pressed for time, here's the short explanation: this 1976 amendment of  the Food, Drug and Cosmetic Act allows manufacturers of medical devices to have their products “pre-approved” by the FDA if it can be shown that they are “substantially similar” to a product that had previously been given approval through the regular process -even if the earlier devices had later been recalled due to defects.

This is how approved FDA medical devices such as the metal-on-metal (MoM) joint replacements and vaginal slings, which have caused a plethora of health problems for patients who have received them, made their way onto the market so quickly. Unfortunately, under the 510(k) law as it now stands, the FDA has no authority to force these manufacturers to demonstrate that any flaws in such a device have been corrected.

This month, Consumer Union – an advocacy organization affiliated with Consumer Reports – took out a full-page ad in the journal Politico as the U.S. Senate prepares to re-authorize these regulations. As you might expect, however, the voices of the Big-Money fueled  FDA medical devices lobby (primarily the trade association, AdvaMed) has drowned out those of consumer advocates – as usual.  Instead, these lobbyists insist that the FDA already has the authority to regulate such devices, and that no amendments to the current law are necessary. However, although the FDA can “invalidate the use of a device” that previously approved model by initiating a recall, the process for making such a recall mandatory can take several years. If a manufacturer initiates a “voluntary” recall, the FDA loses all its authority under existing rules.

On its website, Consumer Union posts a number of facts that thoroughly contradict the claims made by the medical device lobby. Included in this online article is a powerful statement from Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who says: “The problem now is if there’s a problem, it can get replicated…a device is five times as likely to be recalled with a design flaw if it was based on a predicate [previous version] that was itself pulled for safety problems” (italics mine). 

Unfortunately, neither the House nor the Senate version of the bill does anything to close the 510(k) loophole – despite the fact that, according to a Consumer Union poll, more than 70 percent of Americans believe that the loophole should be eliminated.


No surprise there...




N/A. “Medical Device Loophole Leaves Patients At Risk: Consumers Union Responds to Medical Device Industry on Recalled Predicates.” Consumer Union, 21 May 2012. Available at http://safepatientproject.org/document/medical-device-loophole-leaves-patients-at-risk .


Staff Writer. “Dangerous Medical Device Loophole Puts Patients at Risk.” Kansas City InfoZine, 22 May 2011. Available at http://www.infozine.com/news/stories/op/storiesView/sid/51908/ .