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- W2057376502 abstract "A report by the Institute of Medicine recommends that the FDA develop a new regulatory framework for moderate-risk medical devices, currently approved on the basis of their substantial equivalence to previously cleared devices — not assurance of safety or effectiveness." @default.
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- W2057376502 date "2011-09-15" @default.
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- W2057376502 title "Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices" @default.
- W2057376502 doi "https://doi.org/10.1056/nejmp1109150" @default.
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