Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Radiation Biodosimetry Devices." This draft guidance provides recommendations to assist industry in designing studies to establish the analytical and clinical performance characteristics of radiation biodosimetry medical countermeasure devices. This draft guidance is not final nor is it in effect at this time.