FDA COVID-19 EUA Resources

Introduction

UserWise presented on the EUA process this morning. To see the slides, please follow this link.

UserWise recommended joining the next FDA town hall – meeting information is listed at the end of this post.

UserWise also mentioned that n95Decon.org is working to empower hospitals to safely re-use N95 masks to battle COVID-19 based on CDC guidelines

Here are the authorizations for the formally authorized products for facilitating the re-use of N95 masks:
https://www.fda.gov/media/136529/download
https://www.fda.gov/media/136843/download

https://www.fda.gov/media/136884/download

FDA COVID-19 Town Halls: COVID-19 Diagnostic Test Kits

Since April 1, 2020, the U.S. Food and Drug Administration (FDA) has hosted virtual town hall sessions each Wednesday to discuss the development and use of COVID-19 Diagnostic Test Kits. UserWise attended the first meeting and shared takeaways in our earlier post, FDA Q&A Regarding COVID-19 In-Vitro Diagnostic Tests.

Other FDA COVID-19 Webinars

FDA hosts webinars regarding topics beyond COVID-19 in-vitro diagnostic test kits. On April 6, 2020, the agency hosted a webinar for device manufacturers and industry to discuss and answer questions on the two recently-issued, immediately-in-effect guidances on enforcement policy for PPE during COVID-19:

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) (April 2, 2020)
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency (March 30, 2020)

To view the slides and read the transcript, please follow these links.

Webinar Presentation Slides: https://www.fda.gov/media/136704/download
Webinar Transcript: https://www.fda.gov/media/136903/download

The Next FDA Town Hall: Wednesday, April 15, 2020

The next FDA Town Hall occurs tomorrow, Wednesday, April 15, 2020 – there is no need to register. Please see the quoted meeting information, below:

“On April 1, 2020, from 12:15 pm – 1:15 pm Eastern Time, 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 SAR-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 and the recently issued guidance.
More Info: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-town-hall-series-immediately-effect-guidance-coronavirus-covid-19-diagnostic-tests-04012020?utm_campaign=2020-03-27%20April%201-%20Virtual%20Town%20Hall%20COVID-19&utm_medium=email&utm_source=Eloqua

“Registration is not necessary.
Date: Multiple Dates (please see above) Time: 12:15 p.m. – 1:15 p.m. To ensure you are connected, please dial in 15 minutes prior to the start of the call. U.S. Callers Dial:

888-233-1204
Conference Number: RWXW1175579
Passcode: 6110103

“To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=RWXW1175579&p=6110103&t=c
External Link Disclaimer

“Following the webinar, a transcript, recoding, and slides will be posted:
Presentation
External Link Disclaimer
Slides
Transcript”

Additional Free Resources

Watch a short video on how we can help you navigate the EUA process: https://userwiseconsulting.com/EUA-consulting
Book us for a free 1-hour consultation, EUA training, or Human Factors training by emailing us at userwise@userwiseconsulting.com.
Check out the blog posts below with helpful resources for product development during the COVID-19 pandemic.

︎ UserWise Team | April 14, 2020

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