Tighter Devices Regulation Needed

A new report says the FDA’s current oversight of medical devices is inadequate and should be revamped.

By | August 2, 2011


Last Friday, a panel of experts at the Institute of Medicine (IOM)—a nonprofit health division of the National Academy of Sciences—released a report urging the US Food and Drug Administration (FDA) to be more stringent in its regulation of medical devices such as defibrillators and artificial implants. The FDA commissioned the investigation after the recall of several faulty and dangerous devices already in the market, ScienceInsider reports.

One regulatory framework that the report says the FDA should scrap is the “501(k) clearance process," which allows devices an expedited entry into the market if the maker can prove they are similar to devices already in the market. According to a press release from IOM, the FDA’s process “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of moderate-risk devices.

But there have been numerous critics of the report, particularly the producers of such devices, who warn that more stringent regulations would do more harm than good. They argue that tighter regulations will hamper innovation and could ultimately harm patients and cost jobs, the New York Times reports.

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