Date:

September 16, 2020

Time:

12:15 PM - 1:15 PM ET

Summary:

The U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

The FDA will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:

• September 23, 2020 from 12:15 pm - 1:15 pm Eastern Time
• September 30, 2020 from 12:15 pm - 1:15 pm Eastern Time

Add this series to my Calendar
Outlook users: Click link, sel ect 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 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.

？