The FDA 510(k) Approval Process for Medical Devices
As noted, the FDA was not involved in the approval of medical devices until 1976; unfortunately the process under which many hip implants gain approval—the 510(k) program—is believed by many to be a flawed program which fails to properly protect consumers. In 1997, the FDA’s Modernization Act created a fast track mechanism to enable patients to have new drugs sooner. Many wonder whether this is a conflict of interest in that “Big Pharma” contributes over $88 million dollars in user fees each year towards the FDA’s annual $1 billion dollar budget. Despite the FDA’s assertion that the fast track process is both necessary and helpful, the benefits are questionable, particularly whether consumer safety is being adequately protected.
The Premarket Notification part of the 510(k) process allows medical devices to reach the market and be sold throughout the U.S. much sooner. No clinical testing or outcome review is required for devices fast-tracked through the 510(k) program. A study reported on in 2011, showed that of the 113 recalls from 2005-2009, 71% of those medical devices (the vast majority) passed through the 510(k) process with no problems. Twenty-one percent of the recalled medical devices had passed through the more rigorous pre-market approval process and 7% were exempted from review.8
In 2011, the Institute of Medicine conducted an independent analysis, concluding the 510(k) process is “flawed, based on its legislative foundation,” and suggested the FDA develop an “integrated premarket and postmarket regulatory framework,” to assure safety over the life of the device.9 Hip implants happen to be among the most common types of medical devices approved through the 510(k) program and many believe the program needs a total overhaul. While changes to the 510(k) program were proposed in 2010 by the FDA, those proposals were much more benign than many had hoped for with no radical changes to current procedures.
The FDA’s definition of “substantial equivalence,” means that the new device is at least as safe and effective as the device it is based on. The new device must have the same intended use and the same technological characteristics or must have the same intended use and different technological characteristics along with information showing the device does not raise new questions of safety and effectiveness and is at least as safe and effective as the legally marketed device. A claim of substantial equivalence does not mean the new medical device and its predicate are identical, rather they are equivalent based on intended use, design, energy used, materials, performance, safety, effectiveness, labeling, standards or other characteristics.
Should the manufacturer receive a notification from the FDA stating the device is not substantially equivalent, another 510(k) application may be submitted, along with new data, a Class I or Class II designation may be requested, a Premarket Approval Application may be submitted or a reclassification petition must be filed.The reality of the situation is that many hip implant devices are sliding through with a 510(k) approval from the FDA and little to offer consumers in the way of promises of safety. As an example, the recalled DePuy ASR gained FDA 510(k) approval based on the Wright Profemur hip implant which has had extensive problems of its own.