COVID-19 Laboratory IVD (Diagnostics, Molecular)
Click for official SAM (FBO) notice, additional information, and accompanying attachments
The Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS) seeks to fund the necessary activities and clinical evaluations so an organization can transition their over the counter COVID-19 diagnostic tests from EUA to 510(k) and CLIA waiver. Among other things, the diagnostic test should be easy to use and not require external readers. See attached Combined Synopsis/Solicitation (CSS) for complete requirement details.