QandA(v1)_75A50121R00037.pdf

This document contains a question and answer session regarding a federal solicitation for COVID-19 diagnostic tests. The Biomedical Advanced Research and Development Authority within the Department of Health and Human Services seeks to fund activities to transition over-the-counter COVID-19 diagnostic tests from EUA to 510(k) clearance and CLIA waiver. The diagnostic tests should be easy to use without external readers. Offerors must submit proposals by May 13, 2021. The funding will support necessary clinical evaluations and activities so organizations can commercialize their over-the-counter COVID-19 diagnostic tests for at-home use without requiring a prescription or involvement of a healthcare provider.