In July 2011 the Institute of Medicine (IOM), the medical branch of the National Academy of Sciences, joined the group of voices calling on the Food and Drug Administration (FDA) to reform its 501(k) approval process for medical devices when it issued its report Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years. The IOM argues in its report that the FDA’s 501(k) approval process is fatally flawed and does not offer enough protections to guarantee consumers the safety of medical devices, as evidenced by the shocking number of dangerous medical devices that have made it through the 501(k) approval process. It is important for consumers to understand how the FDA approves medical devices and how that process may put them at risk.
The 501(k) Approval Process
The FDA classifies medical devices in three categories:
- Class III: “high-risk” devices such as implantable heart valves or intraocular lenses
- Class II: “moderate-risk” devices such as lasers or MRI equipment
- Class I: “low-risk” devices such as tongue depressors or manual wheelchairs
Currently, the FDA requires extensive premarketing testing and approval for class III devices, and the manufacturers of such devices need to prove to the FDA that they are “safe and effective” before the FDA will grant the approval. The FDA requires limited review and premarketing approval for class II devices. The manufacturers of such devices need only demonstrate to the FDA that the devices are “substantially similar” to a device already on the market. The FDA does not require premarketing approval for class I devices.
Lawmakers intended the 501(k) process to be streamlined and to allow devices to get to the market faster. According to IOM statistics, approximately 90 percent of medical devices introduced to the market go through the 501(k) process.
Criticisms of the Process
Critics of the 501(k) process are particularly troubled by the FDA’s treatment of class II devices. The FDA has acknowledged that finding a device is substantially similar to a device already on the market does not ensure that the new device is safe. A new device might show that it is similar to a device put on the market in 2003, which may have been approved because it was similar to a device put on the market in 1995, and so on until the regression chain reaches a device on the market when the law providing for the 501(k) process went into effect in 1976 – and that initial device might not have been tested for safety and effectiveness.
The number of class II devices that manufacturers have had to recall because of safety defects lends credence to the criticisms of the current process. Many recent high profile medical device recalls, including the recalls of the DePuy ASR hip implant and the Bard G2 IVC filter, involved devices with 501(k) approvals. According to a study published in the July 2011 issue of the Archives of Medicine revealed that of 113 medical devices subject to recalls between 2005 and 2009 because they caused serious injury or death, 80 of the devices had gone through the 501(k) approval process.
The IOM report claimed that the 501(k) process was hopelessly flawed and the FDA would be better served dedicating its limited resources to designing an entirely new approval protocol for medical devices rather than trying to fix the 501(k) process. The IOM asserted that the 501(k) process does not offer sufficient protections to prevent medical devices from causing tragedies such as those that resulted from the DePuy ASR hip implant, where doctors discovered the device leaked dangerous amounts of chromium and cobalt into patients’ bloodstreams after over 93,000 people had received the implants worldwide. Patients with the implant had to undergo painful removal surgery and may continue to suffer debilitating pain even after the device is out of their bodies.
At the moment, the FDA is more inclined to amend the 501(k) process than eliminate it completely, and an FDA spokesman claimed that the agency was “open to additional proposals and approaches for continued improvement of our device review programs.” Consumers have a right to be wary of any device that has received FDA 501(k) approval, though, without substantial reform to the process.