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By Linda W. Lewis

In July 2011, the Institute of Medicine (IOM) issued a report commissioned by the United States Food and Drug Administration assessing the FDA’s medical device approval process. While the report emphasized that most medical devices now in use are safe, it recommended that the FDA completely revamp its current 510(k) process, which allows moderate-risk devices that are substantially equivalent to those already on the market, to gain clearance without proof of safety or effectiveness.
“The system is broken whether you look at it from the consumer view, the government view or the manufacturer perspective. Patient advocates want complete safety, but making a device totally without risk is impossible,” says Raymond Lanzafame, MD, MBA, FACS, who serves as an SGE (special government employee) consultant to the FDA’s General and Plastic Surgery Devices Panel of the Center for Devices and Radiological Health (CDRH) Office of Device Evaluation (ODE). “On the other hand—say consumers and manufacturers—just look at all the technology around the world that we cannot use here because the approval process is so slow. The FDA is caught between these opposing realities.”

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