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Webinar Materials

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Summary:

On May 15, 2020, from 1:00-2:00 p.m. Eastern Time, the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 public health emergency.  This is a collaboration between the FDA, the Department of Veterans Affairs’ (VA) Innovation Ecosystem, and the National Institutes of Health’s (NIH) 3D Print Exchange. 

During this town hall, representatives from each of these three Agencies will discuss the activities of this collaboration, including the current proposed regulatory science research aims regarding the design, manufacturing, and use of 3D printed swabs during the COVID-19 public health emergency.

Representatives from these three Agencies will also provide an overview of their partnership, including discussion of best scientific practices and processes for the manufacture and validation of these 3D printed products. We will also answer technical questions about the proposed scientific research regarding the development and validation of swabs manufactured through unconventional means for use with COVID-19 testing.

Background:

The FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (Revised) was issued on February 29,2020 to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the emergence of this rapidly spreading, severe illness. This guidance was updated on March 16, 2020, May 4, 2020, and May 11, 2020.