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Summary:

The U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for SARS-CoV-2 test developers. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

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

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

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The FDA will hold a virtual Town Hall for test developers to help answer questions on:

• November 17, 2021 from 12:15 p.m. - 1:15 p.m. Eastern Time
• December 1, 2021 from 12:15 p.m. - 1:15 p.m. Eastern Time
• December 15, 2021 from 12:15 p.m. - 1:15 p.m. Eastern Time

Background:

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

The immediately in effect guidance "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)" includes policies specific to this public health emergency. This guidance was issued on February 29, 2020 and subsequently updated on March 16, 2020, May 4, 2020, and May 11, 2020.

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

Stakeholder Call Details:

Registration is not necessary.

Time: 12:15 p.m. – 1:15 p.m.
To ensure you are connected, please join 15 minutes prior to the start of the virtual town hall.

Please click the link below to join the webinar:

https://fda.zoomgov.com/j/1604819799?pwd=TnY4QnVHQnMzRGliYng5TVpmQTFRUT09

Passcode: x^2jdD

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: 669-254-5252
Webinar ID: 160 481 9799
Passcode: 395574

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

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