CDRH Virtual Town Hall Series 

Test Development and Validation During 

Public Health Emergencies 

(#100: Monkeypox (mpox) and COVID-19) 

January 11, 2023 

Toby Lowe, Kristian Roth, Ph.D. and Noel Gerald, Ph.D. 

Center for Devices and Radiological Health 
 

 

Upcoming Virtual Town Halls 

Date Topic 

Feb 15, 2023 Monkeypox (mpox) and COVID 

Time: 12:05 – 1 PM ET 

Medical Device Webinars and Stakeholder Calls: 

www.fda.gov/medical-devices/workshops-conferences-medical-devices/medical-device-webinars-and-stakeholder-calls 

Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and Monkeypox): 

www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-town-hall-series-test-development-andvalidation-during-public-health-emergencies-covid-19 

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CDRH Learn 

www.fda.gov/Training/CDRHLearn 

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Opening Remarks – Monkeypox (mpox) Updates 
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Opening Remarks - COVID-19 Updates 
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Previously Emailed Questions 
 

 

 

 

 

 

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Resources for Monkeypox (mpox) Test Development and Validation 

How to Receive Updates/Alerts and Ask Questions by Email: 

• Subscribe to CDRH Email Lists (e.g., Monkeypox and Medical Devices, In Vitro Diagnostics): 

www.fda.gov/about-fda/center-devices-and-radiological-health/subscribe-cdrh-mailing-lists 

• For questions about Monkeypox (mpox) IVD EUAs, email: MPXDx@fda.hhs.gov 

Where to Find Information: 

• Monkeypox and Medical Devices: www.fda.gov/medical-devices/emergency-situations-medicaldevices/monkeypox-and-medical-devices 

• Monkeypox Emergency Use Authorizations for Medical Devices: www.fda.gov/medicaldevices/emergency-use-authorizations-medical-devices/monkeypox-emergency-use-authorizationsmedical-devices 

• Policy for Monkeypox Tests To Address the Public Health Emergency: www.fda.gov/regulatoryinformation/search-fda-guidance-documents/policy-monkeypox-tests-address-public-health-emergency 

• EUA Templates to assist developers: www.fda.gov/medical-devices/emergency-use-authorizationsmedical-devices/monkeypox-emergency-use-authorizations-medical-devices#templates 

• Frequently Asked Questions on Testing for Monkeypox: www.fda.gov/medical-devices/monkeypox-andmedical-devices/faqs-testing-monkeypox 
 

 

 

 

 

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Resources for COVID-19 Test Development and Validation 

How to Receive Updates/Alerts and Ask Questions by Email: 

• To receive CDRH IVD update/alert emails, subscribe to the In Vitro Diagnostics Mailing List: 

www.fda.gov/about-fda/center-devices-and-radiological-health/subscribe-cdrh-mailing-lists 

• For questions about COVID-19 IVD EUAs, email: COVID19DX@fda.hhs.gov 

• For questions about laboratory data harmonization for COVID-19 testing, email: 

SHIELD-LabCodes@fda.hhs.gov 

Where to Find Information: 

• In Vitro Diagnostics EUAs: www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-useauthorizations-medical-devices/vitro-diagnostics-euas 

• Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency: www.fda.gov/regulatoryinformation/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-healthemergency-revised 

• FAQs on Testing for SARS-CoV-2 (Includes: Notifications and Emergency Use Authorizations, At-Home COVID-19 

Diagnostic Tests, Test Development and Review, Test Uses, Testing Supplies, and COVID-19 Related Test Data and 

Reporting): www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2 

• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: 

www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetingsmedical-device-submissions-q-submission-program 

• NIH Independent Test Assessment Program (ITAP): www.nibib.nih.gov/covid-19/radx-tech-program/ITAP 
 

 

 

 

Let’s Take Your Live Questions 

• To Ask a Question: 

1. Raise your hand in Zoom 

2. Moderator will announce your name and invite you to ask your question 

3. Unmute yourself when prompted in Zoom to ask your question 

• When Asking a Question: 

4. Announce your first, last, and business name 

5. Ask one question only 

6. No questions about specific submissions 

• After Question is Answered: 

7. Mute yourself and lower your hand 

8. If you have more questions - raise your hand again 

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Thanks for Joining Today! 

• Presentation and Transcript will be available at: 

• CDRH Learn: www.fda.gov/Training/CDRHLearn 

• Under the “In Vitro Diagnostics” section and “Virtual Town Hall Series” subsection 

• If you have additional questions about monkeypox (mpox) diagnostic development: 

• Email: MPXDx@fda.hhs.gov 

• If you have additional questions about COVID-19 diagnostic development: 

• Email: COVID19DX@fda.hhs.gov 

• Upcoming Webinars: 

• www.fda.gov/CDRHWebinar 

Next Virtual Town Hall (Monkeypox (mpox) and COVID-19) 

Feb 15, 2023 from 12:05 – 1 PM ET