CDRH Industry: Radiation Biodosimetry Medical Countermeasure Devices - Guidance for Industry and FDA Staff

The U.S. Food and Drug Administration has issued a guidance titled, 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 (e.g., clearance or approval) for radiation biodosimetry medical countermeasure devices. This guidance applies to premarket submissions for medical device systems intended to measure biological responses to unintended (non-therapeutic) radiation absorption.