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Summary:

The U.S. Food and Drug Administration (FDA) hosts regular virtual Town Halls for SARS-CoV-2 test developers. The purpose of these Town Halls is to help answer technical questions about the development and validation of tests for SARS-CoV-2. Registration is not necessary.

There will be an opportunity to ask questions live during the Town Halls, but questions may also be submitted in advance by emailing [email protected].

• Please submit questions by Monday 12 p.m. ET before the Wednesday virtual Town Hall.
• In the subject line of the email, state "Question for the COVID-19 Test Virtual Town Hall"

Save the Date:

The FDA will hold a virtual Town Hall for test developers from 12:05 p.m.-1 p.m. ET on:

• June 15: Town Hall #87    
• June 29: Town Hall #88

Add May and June Dates to My Calendar
Outlook users: Click link, select Open, then click Save & Close

Background:

The FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including Coronavirus Disease 2019 (COVID-19). The FDA is committed to providing timely guidance to support response efforts to this pandemic.

The guidance "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)" includes policies specific to this public health emergency. 

The recording and transcript from the previous town halls are available for viewing.

Stakeholder Call Details:

Registration is not necessary.

Time: 12:05 p.m. - 1 p.m. ET
To ensure you are connected, please join 15 minutes before the start of the virtual Town Hall.

Please click the link below to join the webinar:

https://fda.zoomgov.com/j/1604039621?pwd=Z09BRkJKR0F2c1g0Zk1KMFVKZ2MvZz09
Passcode: 5Brwk#

Please note: Participants who join the virtual Town Hall using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining the virtual Town Hall by phone only.

Dial: 833-568-8864
Webinar ID: 160 403 9621
Passcode: 771581

Following the webinar, a transcript, recording, and slides will be posted below.

Previous Town Halls from the Coronavirus (COVID-19) Test Development and Validation Series