Report Urges FDA to Scrap 510(K) Medical Device Approvals

A medical watchdog has called for the elimination of the system the U.S. Food & Drug Administration (FDA) uses to approve most <"">medical devices. According to a panel from the Institute of Medicine, that streamlined process, known as 510(k) approval, offers patients no assurance of safety.

As we’ve reported in the past, 510(k) approvals are permitted when a new medical device is deemed to be substantially similar to others already on the market. As 510(k) medical devices require no human clinical trials, the process is much quicker than standard approvals, taking only about 10 months. According to the Institute of Medicine, about 90 percent of the medical devices brought to market are done so through 510(k) approvals.

According to The New York Times, the Institute of Medicine is a widely respected organization that assembles experts to study a range of health-related issues. In 2009, he FDA had asked the Institute of Medicine to conduct a review of 510(k) approvals as part of a review of its device unit. That unit has been plagued by serious problems in recent years, including several high-profile medical device recalls.

Unfortunately, medical devices that undergo the streamlined 510(k) approval process tend to be recalled most frequently, according to recent research. For instance, a study published last month in the journal Archives of Internal Medicine found that of 113 medical devices recalled between 2005 and 2009 because they could cause serious health problems or death, 80 had undergone 510(k) approvals. Many of those devices were recalled because of concerns the product could kill or seriously harm a patient.

One of the most recent 510(k) recalls involved <"">DePuy Orthopaedic’s ASR hip implants. Just last August, DePuy, a division of Johnson & Johnson, issued a worldwide recall of the devices because of concerns they might shed dangerous amounts of cobalt and chromium into recipients’ bloodstreams. By the time the recall was issued, DePuy ASR hip implants had been implanted in 93,000 people around the world. Many of those recipients have been forced to undergo painful revision surgeries, and an unknown number will likely need to have the faulty implants removed at some point in the future. Even once the implant is removed, many DePuy ASR hip implant patients will continue to suffer excruciating pain and disability.

Because of these types of problems, the Institute of Medicine has recommended the FDA scrap the 510(k) process entirely.

“The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of moderate-risk devices, the report concluded, adding, “furthermore, that it cannot be transformed into one.”

The report recommended that the FDA not spend its very limited resources to reform the 510(k) process, but instead formulate an entirely new medical device approval protocol.

The report’s recommendations are not setting well with the industry. Even before the Institute of Medicine released its report, the medical device industry and its proxies were attacking it. A month ago, for example, the Washington Legal Foundation, a pro-business group, filed a petition with the FDA arguing that the agency was statutorily barred from adopting any of the report’s recommendations because of what it claimed was the panel’s bias, according to The New York Times. The group pointed out that the panel that authored the report did not include officials from industry, the investment community or patients who had benefited from devices.

Once the Institute of Medicine report was released last week, the industry was even more scathing in its criticism.

“The report’s conclusions do not deserve serious consideration from Congress or the administration,” Stephen Ubl, president of the Advanced Medical Technology Association, said in its statement. “It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure.”

For its part, the FDA does not seem inclined to take the Institute of Medicine’s advice that it scrap 510(k) approvals.

“FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” Dr. Jeffrey E. Shuren, the director of the FDA Center for Devices and Radiological Health, said in a statement released Friday in response to the Institute of Medicine report.

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