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# CDRH Guide on Radiation Biodosimetry Devices
- URL: https://www.fdaweb.com/cdrh-guide-on-radiation-biodosimetry-devices/
- Published: 2016-04-15T12:00:00.000Z
- Updated: 2026-09-14T20:54:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135380

> CDRH has released a [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM427866.pdf?ref=fdaweb.com) on “Radiation Biodosimetry Medical Countermeasure Devices” that provides recommendations on the information that should be submitted to support marketing authorization for devices intended to measure biological responses to unintended (non-therapeutic) radiation absorption. Biodosimetry devices are used for reconstructing the ionizing radiation dose received by individuals or populations using physiological, chemical, or biological markers of exposure found in humans. “Devices may be designed to give quantitative outputs or qualitative information around a clinical decision making cut-point,” the document says. “Likewise, devices may be designed for use in field triage settings, at patient bedsides, or in Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified clinical laboratories.”