A new guidance document titled Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices has recently been posted. This guidance describes the device operation conditions for magnetic resonance diagnostic devices that FDA considers significant risk for the purposes of determining whether a clinical study requires Agency approval of an Investigation Device Exemption (IDE). Magnetic resonance diagnostic devices are class II devices described under 21 CFR 892.1000. For more information, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072686.htm
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