• Summary
• Background
• Meeting Materials

Summary

The U.S. Food and Drug Administration (FDA) will host a webinar about the recently published final guidance, Policy for Monkeypox Tests to Address the Public Health Emergency. During this webinar the FDA will provide highlights of the final guidance and answer questions from webinar attendees.

Registration is not necessary.

There will be an opportunity to ask questions live on the webinar, but questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov. In the subject line of the email, state "Question for the Monkeypox Tests Webinar": 

• Submit questions in advance by Monday, September 12, 2022, at 5 p.m. ET.

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Background

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the recent monkeypox outbreak.

The guidance, Policy for Monkeypox Tests to Address the Public Health Emergency, issued on September 7, 2022, describes:

• Review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests,
• Enforcement policies for certain diagnostic tests that are developed by and performed in a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) that meets the requirements to perform tests of high complexity,
• Enforcement policies for FDA-cleared or authorized monkeypox diagnostic tests that are modified,
• Enforcement policies for certain serology tests, and
• Recommendations for diagnostic test validation.

Meeting Materials

Registration is not necessary.

Time: 12:05 p.m. - 1 p.m. ET on September 14, 2022

To ensure you are connected, please join 15 minutes before the start of the webinar.

Please click the link below to join the webinar:
https://fda.zoomgov.com/j/1612083563?pwd=NklWOE1jUlU2dUVlNWtvQTNkdTM5UT09
Passcode: ^8@HvK

Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through computer speakers and speak through computer microphone/headset to ask a question).

The dial-in information provided below is for participants who will be joining the webinar by phone only.

U.S. Callers Dial: 833-568-8864 (Toll Free)
International Callers Dial: Please check the international numbers available
Webinar ID: 161 208 3563
Passcode: 728477

The printable slides are available.  After the webinar, the presentation and transcript will be available at CDRH Learn under "Specialty Topics", sub-section "Public Health Emergencies."