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  5. Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - 10/06/2021 - 10/06/2021
  1. Workshops & Conferences (Medical Devices)

Town Hall

Event Title
Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
October 6, 2021


Date:
October 6, 2021
Time:
12:15 PM - 1:15 PM ET

 

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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 CDRHWebinars@fda.hhs.gov.

  • Please submit questions by Monday 12pm 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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Save the Date:

  • October 20, 2021 from 12:15 pm – 1:15 pm 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/1618906614?pwd=aUVJVmlaRDU1UUE2bkpvanBqbG1wdz09

Passcode: M^8hc+

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: 161 890 6614
Participant ID: #
Passcode: 880323

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

Series Number Date Materials
1 March 25, 2020 Presentation   Transcript   Slides
2 April 1, 2020 Presentation   Transcript
3 April 8, 2020 Presentation   Transcript
4 April 15, 2020 Presentation   Transcript
5 April 22, 2020 Presentation   Transcript
6 April 29, 2020 Presentation   Transcript
7 May 6, 2020 Presentation   Transcript
8 May 13, 2020 Presentation   Transcript
9 May 20, 2020 Presentation   Transcript
10 May 27, 2020 Presentation   Transcript
11 June 3, 2020 Presentation   Transcript
12 June 10, 2020 Presentation   Transcript
13 June 17, 2020 Presentation   Transcript
14 June 24, 2020 Presentation   Transcript
15 July 1, 2020 Presentation   Transcript
16 July 8, 2020 Presentation   Transcript
17 July 15, 2020 Presentation   Transcript
18 July 22, 2020 Presentation   Transcript
19 July 29, 2020 Presentation   Transcript
20 August 5, 2020 Presentation   Transcript
21 August 12, 2020 Presentation   Transcript
22 August 19, 2020 Presentation   Transcript
23 August 26, 2020 Presentation   Transcript
24 September 2, 2020 Presentation   Transcript
25 September 9, 2020 Presentation   Transcript
26 September 16, 2020 Presentation   Transcript
27 September 23, 2020 Presentation   Transcript
28 September 30, 2020 Presentation   Transcript
29 October 7, 2020 Presentation   Transcript
30 October 14, 2020 Presentation   Transcript
31 October 21, 2020 Presentation   Transcript
32 October 28, 2020 Presentation   Transcript
33 November 4, 2020 Presentation   Transcript
34 November 18, 2020 Presentation   Transcript
35 December 2, 2021 Presentation   Transcript
36 December 9, 2020 Presentation   Transcript
37 December 16, 2020 Presentation   Transcript
38 January 6, 2021 Presentation   Transcript
39 January 13, 2021 Presentation   Transcript
40 January 27, 2021 Presentation   Transcript
41 February 3, 2021 Presentation   Transcript
42 February 10, 2021 Presentation   Transcript   Slides
43 February 17, 2021 Presentation   Transcript
44 February 24, 2021 Presentation   Transcript
45 March 3, 2021 Presentation   Transcript
46 March 10, 2021 Presentation   Transcript
47 March 17, 2021 Presentation   Transcript
48 March 24, 2021 Presentation   Transcript
49 March 31, 2021 Presentation   Transcript
50 April 7, 2021 Presentation   Transcript
51 April 14, 2021 Presentation   Transcript
52 April 21, 2021 Presentation   Transcript
53 April 28, 2021 Presentation   Transcript
54 May 5, 2021 Presentation   Transcript
55 May 12, 2021 Presentation   Transcript
56 May 19, 2021 Presentation   Transcript
57 May 26, 2021 Presentation   Transcript
58 June 2, 2021 Presentation   Transcript
59 June 9, 2021 Presentation   Transcript
60 June 16, 2021 Presentation   Transcript
61 June 23, 2021 Presentation   Transcript
62 June 30, 2021 Presentation   Transcript
63 July 14, 2021 Presentation   Transcript
64 July 28, 2021 Presentation   Transcript
65 August 4, 2021 Presentation   Transcript
66 August 11, 2021 Presentation   Transcript
67 August 18, 2021 Presentation   Transcript
68 August 25, 2021 Presentation   Transcript
69 September 8, 2021 Presentation   Transcript
70 September 22, 2021 Presentation   Transcript
71 October 6, 2021 Presentation   Transcript

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