Timothy Stenzel, M.D., Ph.D., Toby Lowe, Kristian Roth, Ph.D. and Noel Gerald, Ph.D. 

Center for Devices and Radiological Health

CDRH Virtual Town Hall Series 

Test Development and Validation During 

Public Health Emergencies 

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

February 15, 2023
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www.fda.gov/Training/CDRHLearn

CDRH Learn
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Upcoming Virtual Town Hall

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/medicaldevices/workshops-conferences-medical-devices/virtual-town-hall-series-test-development-and-validation-during-public-health-emergencies-covid-19

Date Topic

March 22, 2023* Monkeypox (mpox) and COVID

*This will be our last regularly scheduled virtual town hall; however, we will announce any 

ad hoc virtual town halls if and when special topics come up in the future.
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Opening Remarks – Monkeypox (mpox) Updates

• 2/10: Cepheid Xpert Mpox Test Authorized 

• www.fda.gov/medical-devices/emergency-use-authorizationsmedical-devices/monkeypox-mpox-emergency-use-authorizationsmedical-devices
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Opening Remarks - COVID-19 Updates

• 1/12: Updates to COVID - 19 testing guidances to reflect duration of EUA declaration 

• Policy for Coronavirus Disease - 2019 Tests (Revised): Guidance for Developers and Food and Drug Administration 

Staff; www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-

•

tests - during-public-health-emergency-revised

Policy for Evaluating Impact of Viral Mutations on COVID - 19 Tests: Guidance for Test Developers and Food and 

Drug Administration Staff; www.fda.gov/regulatory-information/search-fda-guidance-documents/policyevaluating-impact-viral-mutations-covid-19-tests

• 1/30: Biden Administration announced it will end the public health emergency declaration on May 11, 

2023 

• Refer to What will happen with tests offered under EUA if the public health emergency expires and is not 

renewed? www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/notifications-andemergency-use-authorizations-faqs-testing-sars-cov-2

• 2/6: Updates to the easy step-by-step guide to include information about reporting your over-thecounter (OTC) at - home COVID - 19 test result to MakeMyTestCount.org 

• Understanding At - Home OTC COVID - 19 Antigen Diagnostic Test Results; www.fda.gov/medicaldevices/coronavirus-covid-19-and-medical-devices/understanding-home-otc-covid-19-antigen-diagnostic-testresults
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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-medical-

•

devices/monkeypox - and - medical - devices

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

•

medical - 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-authorizations-

•

medical - 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-health-

•

emergency - 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
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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) 

March 22, 2023 from 12:05 – 1 PM ET