Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices
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...
Paper Details
Title
Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices
Published Date
Sep 15, 2011
Volume
365
Issue
11
Pages
977 - 979
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