Hi Richard,

You should complete a full validation of the instrument with a SARS-CoV-2 assay .

FAQs on Testing for SARS-CoV-2 are available for your review and templates for IVD these EUA submissions are available on our website to help facilitate the preparation, submission, and authorization of an EUA:

Molecular Diagnostic Template for Commercial Manufacturers (updated July 28, 2020) Home Specimen Collection Molecular Diagnostic Template (May 29, 2020) Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use (July 29, 2020

Respectfully, Yvonne COVID19DX IVD Team CDRH U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

• FAQs on Testing for SARS-CoV-2
• Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised)
• In Vitro Diagnostics EUAs
• Molecular Diagnostic Template for Commercial Manufacturers
• Molecular Diagnostic Template for Commercial Manufacturers
• Home Specimen Collection Molecular Diagnostic Template
• Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use