FDA has updated the Antigen Template for Test Developers on FDA.gov. This template provides the FDA’s current recommendations concerning data and information that should be submitted to the FDA in support of an EUA request for a SARS-CoV-2 antigen test. This new update adds recommendations regarding studies to support claims for screening asymptomatic individuals and multiplexed antigen tests.
The template reflects the FDA’s current thinking on the topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The FDA is open to alternative approaches.
To download the template, visit FDA.