FDA issued a draft guidance “Radiation Biodosimetry Devices” dated Dec. 30, 2014. This guidance focuses on performance data and algorithm feature selection as well as labeling. Section V.G. idnicates electronic data submisiioon is encouraged but should include the programs used to genereate results should be incliuded in a way that can be easilty transferred into statitistical software. Section C.8 Instrumentation and Software simply references FDA’s general software submissions guidances.