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  • FDA templates for EUA Submissions

    For the most up-to-date templates, please visit: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas The link will direct you to the Diagnostic Templates (Molecular and Antigen), as well as the Serology/Antibody Templates.

  • Regulatory Info for RADx-rad Awardees

    This document contains regulatory information for RADx-rad Awardees preparing an EUA submission.