Radiation Biodosimetry Medical Countermeasure Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Radiation Biodosimetry Medical Countermeasure Devices." FDA has developed this guidance to provide industry and Agency staff with recommendations for the types of information that should be submitted to support marketing authorization for radiation biodosimetry medical countermeasure devices.