IOM: FDA Should Abandon 510(k) But Agency, Industry Disagree

08.02.11
Publication: FDAnews By: Virgil Dickson

The FDA should abandon its 510(k) device clearance process and develop a new regulatory framework for low- and moderate-risk medical devices, a report by the Institute of Medicine (IOM) suggests.

The report immediately drew fire from the device community, despite the FDA’s assertion that it has no plans to follow IOM’s advice.

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