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Home » IOM: FDA Should Abandon 510(k) But Agency, Industry Disagree
IOM: FDA Should Abandon 510(k) But Agency, Industry Disagree
August 1, 2011
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. Devices & Diagnostics Letter
