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FDA 510(k) Approval Process — When faster is not always better


Apparently, the FDA will expedite its abbreviated 510K approval process.  The medical device industry is painting this as an improvement in the device approval process, but at what cost?  And, for who is this expedited clearance process an improvement?

According to an analysis from the medical device consulting company Emergo Group, 42% of medical devices submitted for approval were cleared within three months in 2011.  That seems fast, and one must wonder what short-cuts are being taken to expedite the approval and whether patient safety is priority one?

Most patients believe there are doctors and scientists donning white lab coats at the FDA and painstakingly performing independent testing and experiments to substantiate the safety of new drugs and medical devices.  The reality, however, is quite different.  The FDA does no independent testing, and, rather, drug and medical device safety approval process is based essentially on the honor system.  Regarding medical devices, where the approval process has the most gaping holes in patient safety, device manufacturers can obtain approval to sell a new medical product to be placed in patient’s bodies with the exchange of a few thousand dollars and review a paperwork for a few hours by overburdened FDA personnel.  Most patients would be shocked to realize how little effort is put into determining the safety of medical product prior to approval for sale and after sale when they have the greatest potential to harm.

Historically, the medical device industry has complained it takes too long and is too costly to bring a new medical device onto the market, even though a few thousand dollars and a few months wait hardly seems like a long time.  The FDA has succumbed to political pressures in the past to create short-cuts, many of which have led to some of the most dangerous medical devices ever marketed.  Some medical devices undergo a rigorous approval process known as a Pre-Market Approval (or “PMA), which can involve thousands of hours of review of safety and efficacy data from clinical trials by FDA officers.  For other medical devices subject to the abbreviated 510(k) approval process, the review is far less rigorous and often involves only a few hours of FDA scrutiny.  In the 510(k) process, the review is focused on whether a new medical device is “substantially equivalent” to another device (known as the “predicate device”) which has already been approved by the FDA.  This 510(k) approval process has numerous gaps that have led to patient injuries and deaths.  For instance, two devices that are “substantially equivalent” could have significant differences in their properties, such that they do not perform in the same manner once implanted in patients’ bodies.  Also, if a predicate device is recalled or removed from the market due to safety concerns, there is not an automatic recall or review of the safety of other devices approved under the 510(k) process based upon the predicate device.

Emergo Group looked at over 18,000 medical device applications and found that the average 510(k) review times fell to 138 days in 2011 from 146 in 2010. And 510(k) approval jumped to 41% from 40% in 2010.  The vast majority – 95 to 97 percent – of medical devices are cleared for marketing within one year from submission to the FDA with no assurances for safety and efficacy. The study also found that half of all medical devices submitted for 510(k) clearance were in the orthopedic, cardiovascular, general, plastic surgery or radiology categories, arguably the medical devices most likely to cause serious patient injuries or death if they were defective. Among the most common medical devices to receive the fast-track 510(k) approval are permanently implanted include dental implants, bone filler, surgical mesh, knee implants, spinal implants, and surgical screws.

Industry calls this a “more efficient” FDA “medical device regulatory process,” but it’s tough to imagine that a faster fast-track is a system that would be considered good news to most patients.  The 510(k) approval process is responsible for the approval of a number of medical devices that are currently the subject of litigation, including metal-on-metal hip implants (manufactured by Wright Medical, Zimmer, Biomet, and DePuy); modular hip implants (such as the Stryker ABGII, Rejuvenate and Accolade models); transvaginal mesh, bladder slings, and TVT tape; NuvaRing; and Mirena.

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