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More Information on the Device Review Process

Statement: GAO Report Documents Lax Device Approval Standards at FDA

January 15, 2009

Peter Lurie, M.D., M.P.H., Deputy Director, Public Citizen’s Health Research Group

A Government Accountability Office (GAO) report* released today highlighting the dismal job the Food and Drug Administration (FDA) does in regulating medical devices shows that the approval process at the FDA is irredeemably broken. The report criticizes the agency’s regulation of some of the most complex and risky devices and concludes that many high-risk devices are going through a less-stringent review process before being used in patients.

Further, the GAO found that the FDA routinely approves medical devices using lax testing standards and has failed to complete a review of riskiest of these devices as required under a congressional mandate.

The bottom line is that the American people deserve new leadership that will not blithely ignore congressional mandates, placing the health of tens of thousands of Americans at risk.

Congress intended that the most risky medical devices -- those classified as “Class III” -- be approved only after undergoing a rigorous procedure called a pre-market application (PMA). An alternative path to market is the less-rigorous 510(k) process. Under this process, rather than having to show that their device is safe and effective through clinical studies, device makers need only show that their device is “substantially equivalent” to one that has already proceeded through the 510(k) process, a so-called “predicate device.”   In a recent example, ReGen Biologics tried to get its Collagen Scaffold device, used during knee surgery, approved as a PMA, but after the randomized controlled trial failed to show clinical benefit, switched to 510(k). The FDA cleared the device on Dec. 18 by downplaying the results of the clinical trial that failed to show it was effective.

Moreover, the GAO report points to the lax standards of the 510(k) pathway, which permits even devices with markedly different technological characteristics to be declared substantially equivalent and thus receive clearance for marketing. All Class I and II devices are approved through this mechanism. According to the GAO, one in seven Class II and III devices cleared by 510(k) between fiscal years 2005 and 2007 had different technological characteristics than their predicate devices. For example, in 2007, Neuronetics sought FDA clearance for its Transcranial Magnetic Stimulation device, which uses magnetic fields to treat depression, through 510(k), with the predicate device being electroconvulsive therapy, which uses electricity. (The product was ultimately approved using an obscure pathway called the de novo process.)

In 1990, Congress mandated that by Dec. 1, 1995, the FDA complete a review of all Class III devices to establish to which class they belonged. In the interim, they could continue to be regulated as 510(k) devices. The GAO documents that for at least 20 types of devices, including certain pacemakers, automatic external defibrillators, and certain artificial hips, the FDA failed to review the devices, allowing American patients to be exposed to minimally reviewed medical devices. The GAO recommends that “the FDA expeditiously take steps to issue regulations for class III device types currently allowed to enter the market via the 510(k) process.”   Though FDA officials acknowledged to the GAO the importance of finishing this tardy task, they “did not provide a time frame for doing so.” The absence of a time frame strongly suggests that this issue is firmly ensconced on the back burner of FDA priorities.

Public Citizen’s testimony opposing the collagen scaffold’s approval
Public Citizen’s testimony opposing the Transcranial Magnetic Stimulation system’s approval

* The GAO report is titled, “Medical Devices; FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process.”

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