Radiation Biodosimetry Medical Countermeasure Devices Guidance for Industry and Food and Drug Administration Staff April 2016
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Guidance Issuing OfficeCenter for Devices and Radiological Health
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 (referred to as “biodosimetry devices” or “biodosimeters” throughout this document). This guidance applies to premarket submissions for medical device systems intended to measure biological responses to unintended (non-therapeutic) radiation absorption. Biodosimetry devices are devices used for the purpose of reconstructing the ionizing radiation dose received by individuals or populations using physiological, chemical, or biological markers of exposure found in humans. Biodosimetry technologies may be used at various stages during triage, including both early mass casualty triage and subsequent clinical evaluation. Such exposures could be the result of intentional harm or as a consequence of a disaster. Devices may be designed to give quantitative outputs or qualitative information around a clinical decision making cut-point. 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. FDA considered both high-throughput and single-use devices in developing this guidance document.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2014-D-2065.