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 COVID19DX@fda.hhs.gov

• FAQs on Testing for SARS-CoV-2
  1. Test Settings
  2. Test Uses
• 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

… Coming from Test Settings

As discussed in the EUA template, an EUA request for a POC test should include data to demonstrate that non-laboratory personnel can perform the test accurately in the intended use environment, as well as data to demonstrate the robustness of the device for near-patient testing, i.e., that the device is not sensitive to environmental and usage variation.