FDA's Fast-Track Medical Device Approval Process Under Fire

April 14, 2011— -- WASHINGTON — The FDA is falling short in how it handles recalls of risky medical devices, a new report from the Government Accountability Office concluded, adding to the ever-mounting criticisms of the agency's fast-track, 510(k) approval process.

The FDA doesn't keep track of the reasons devices such as hip implants are recalled, and it doesn't always follow up to make sure the recall was complete, a GAO investigator told the Senate Special Committee on Aging, which held a hearing Wednesday on FDA's 510(k) process.

"Concerns persist about the effectiveness of the 510(k) process in general, including its ability to provide adequate assurance that devices are safe and effective," Marcia Crosse, director of the GAO's healthcare team, told the committee. "Gaps in FDA's postmarket surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled."

Read this story on www.medpagetoday.com.

The traditional route of device approval — the premarket approval (PMA) process— requires companies to provide clinical data to support their contention that their medical device is safe and effective. The less-stringent 510(k) process does not require clinical trial data; rather, device companies must prove their device is substantially similar to another device already on the market.

The FDA divides medical devices into three categories of risk: class I devices -- such as reading glasses and tongue depressors -- are very unlikely to harm anyone; class II devices are medium-risk, including bone drills and mercury thermometers; and class III includes high-risk devices like pacemakers and heart valves.

Although a federal law requires that all class III devices must eventually go through the pre-market approval process, that is not happening at the FDA.

From 2003-2007, the FDA approved 228 class III devices through the 510(k) process, the GAO report found. The report builds off an earlier report in which the GAO recommended that the 510(k) process not be available for class III devices.

Such devices, the GAO said, should either be reclassified into a less-risky category or else their manufacturers should have to go through the PMA process.