EUA and 510(k) clearance of SARS-CoV-2 Antigen Diagnostic Test

This contract action was awarded under a class Justification & Approval (J&A) in accordance with FAR 6.302-2, Unusual and Compelling Urgency, to facilitate the recovery efforts necessary to address the 2019 Novel Coronavirus (COVID-19). This class J&A is essential to respond to urgent requests for immediate support to respond to the expanding outbreak of COVID-19 which was declared a global pandemic by the World Health Organization (WHO) on March 11, 2020 and a national emergency via a Presidential Proclamation on March 13, 2020. The ultimate spread, length of time, and severity of the COVID-19 outbreak is unknown as this time and current data indicate that COVID-19 has begun to spread exponentially, in the typical pattern for an epidemic. This constitutes an unusual and compelling urgency that demands immediate attention. Immediate acquisition of services and supplies will help ensure that the United States of America remains prepared for and capable of responding to a public health emergency in the necessary and immediate manner that is required.