FDA should invest in developing a new medical device clearance process

The U.S. Food and Drug Administration should gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices, says a new report from the Institute of Medicine. The 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one, concluded the committee that wrote the report.

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