The approval system for medical devices by the Food and Drug Administration has two tracks: Pre-Market Approval (PMA), which involves clinical trials and inspections; or, alternatively, the fast-track 510(k) approval, which only requires a device to be “substantially equivalent” to an existing one. Although the 510(k) process has come under criticism, the precise extent of the risks involved with “fast-tracking” medical device approval has not been studied comprehensively.

A 2011 study by the American Medical Association published in the Archives of Internal Medicine, “Medical Device Recalls and the FDA Approval Process,” examined the initial approval process for 113 devices that were then ultimately recalled by the FDA between 2005 and 2009 for posing serious health risks, including endangering patients’ lives.

The study’s findings include:

• Of the 113 devices recalled between 2005 and 2009 that the FDA determined could cause serious health problems or death, only 21 had been approved through the PMA process (19%). A further 80 (71%) were cleared through the fast-tracked 510(k) process, with an additional eight being exempt from any FDA regulation (7%).
• Devices related to cardiovascular health comprised 31% of the high-risk recalls. Of these, two-thirds were cleared by the 510(k) process.
• The cost of the PMA process is $870,000 per device, whereas the 510(k) process typically costs only $18,000. However, costs associated with recalls and health complications for millions of individual patients using these 113 devices were incalculably high.

The study’s authors conclude that reform of the FDA regulatory process is needed, as most of the dangerous devices recalled were first fast-tracked or were exempt from initial scrutiny.

Tags: safety, technology