On April 26, 2023, 12:05 pm – 1:00pm ET, the U.S. Food and Drug Administration (FDA) will host a virtual town hall for COVID-19 test developers to discuss the two final COVID-19 transition guidances:  

• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and  
• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).   

The panelists for this virtual town hall include: 

• Timothy Stenzel, M.D., Ph.D., Director of the Office of In Vitro Diagnostics 
• Toby Lowe, Acting Deputy Director, Office of In Vitro Diagnostics
• Kristian Roth, Ph.D., Deputy Director of the Division of Microbiology Devices, Office of In Vitro Diagnostics 

We encourage you to submit your questions in advance by emailing CDRHWebinars@fda.hhs.gov.  

• Submit questions by 12 p.m. ET on Monday, April 24, 2023.  
• In the subject line of the email, type “Questions about the transition of test development and validation for COVID-19.”  
• There will also be an opportunity to ask questions live, during the webinar.  
• No registration is required. 

If you cannot attend the live virtual town hall, the recording and transcript will be available at CDRH Learn.  

Questions? 

• See the FAQs on Testing for SARS-CoV-2. 
• For specific questions about COVID-19 diagnostic development, contact COVID19DX@fda.hhs.gov. 
• For general questions about this town hall series, contact Division of Industry and Consumer Education.