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Today’s Topic:

Final Guidance 

Policy for Monkeypox Tests to Address the Public Health Emergency

September 14, 2022
Emergency Use of IVDs for Monkeypox

Toby Lowe

Associate Director for Regulatory Programs

OHT 7: Office of In Vitro Diagnostics 

Office of Product Evaluation and Quality

Kristian Roth, PhD

Deputy Director 

Division of Microbiology Devices

OHT 7: Office of In Vitro Diagnostics 

Office of Product Evaluation and Quality

Timothy Stenzel, MD, PhD 

Director

OHT 7: Office of In Vitro Diagnostics

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

U.S. Food and Drug Administration
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Actions Taken September 7, 2022

FDA Takes Significant Action to Help Expand Access to Testing

www.fda.gov/news-events/press-announcements/monkeypox-update-fda-takes-significant-action-helpexpand-access-testing

• HHS Secretary issues 564 declaration for the emergency use of IVDs for monkeypox

www.hhs.gov/about/news/2022/09/07/hhs-secretary-becerra-issues-564-declaration-to-expand-theavailability-of-testing-for-monkeypox.html

• FDA Guidance: Policy for Monkeypox Tests to Address the Public Health Emergency 

www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-monkeypox-tests-address-publichealth-emergency

• FDA issues first monkeypox emergency use authorization (EUA)

www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-emergency-useauthorizations-medical-devices

*These slides present high level discussion points. Please refer to the guidance document for the details and official policies.
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Assistance for Monkeypox Test Developers

• EUA Templates to assist developers

www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypoxemergency-use-authorizations-medical-devices#templates

• Frequently Asked Questions on Testing for Monkeypox

www.fda.gov/medical-devices/monkeypox-and-medical-devices/faqs-testing-monkeypox

• Virtual Town Halls / Webinar on the Policy for Monkeypox Tests

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

Submit questions in advance to: CDRHWebinars@fda.hhs.gov with“Question for the Monkeypox Tests 

Webinar” in the subject line. 

• Email questions, pre-EUAs, and EUA submissions to: MPXDx@fda.hhs.gov
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Policy for Monkeypox Tests To Address the 

Public Health Emergency

• Describes FDA’s review priorities of emergency use authorization (EUA) 

requests for monkeypox diagnostic tests

• Describes FDA’s enforcement policies for certain diagnostic tests that are 

developed by and performed in a single-site laboratory certified under the 

Clinical Laboratory Improvement Amendments (CLIA) that meets the 

requirements to perform tests of high complexity

• Provides recommendations for diagnostic test validation

• Describes FDA’s enforcement policies for FDA-cleared or authorized 

monkeypox diagnostic tests that are modified

• Describes FDA’s enforcement policies for certain serology tests
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EUA Request Review Priorities

For monkeypox (MPX) diagnostic tests, FDA intends to 

prioritize review of EUA requests for:

• High-throughput diagnostic tests

• Tests with home specimen collection

• Rapid diagnostic tests

All from experienced developers with high manufacturing 

capacity that: 

• Inform FDA (within 30 days of the guidance) of their intent 

to submit an EUA request

*Details in Section IV.A.1 of the Monkeypox Test Guidance
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Overview for Laboratories Developing 

MPX Diagnostic Tests

• FDA will not expect EUA requests for certain MPX diagnostic tests 

when the laboratory notifies FDA (within 5 business days of 

offering test or from date of guidance if already being offered) 

• Developed and performed in a single site CLIA-certified laboratory

certified to perform tests of high complexity;

• Molecular PCR technology; 

• Lesion swabs samples; and

• Appropriately validated.

• FDA will not expect EUA requests for certain validated modifications to 

a cleared or authorized MPX diagnostic test with notification to FDA

*Details in Section IV.A.2 & IV.A.3 of the Monkeypox Test Policy

FDA intends to accept notifications for 

30 days after publication of guidance.
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Overview for Commercial Manufacturers of 

MPX Diagnostic Tests

• FDA expects developers to submit an EUA request or 

premarket submission and receive authorization or clearance 

prior to offering or distributing a monkeypox test

• Inform FDA within 30 days of guidance of intent to submit an EUA 

request – MPXDx@fda.hhs.gov

• FDA does not intend to object to implementation of certain

modifications to a developer’s own cleared or authorized MPX 

diagnostic test while FDA conducts its review

*Details in Section IV.A.1 & IV.A.3 of the Monkeypox Test Policy
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Monkeypox Diagnostics: 

Validation & Templates

• Validation Recommendations in Voluntary Templates

www.fda.gov/medical-devices/emergency-use-authorizations-medicaldevices/monkeypox-emergency-use-authorizations-medical-devices#templates

• EUA Summary Template for Developers of Molecular Diagnostic Tests 

for Monkeypox

• EUA Template for Developers of Molecular Diagnostic Tests for 

Monkeypox

• FDA intends to update recommendations as appropriate as the 

outbreak evolves

*Details in Section IV.B and Section V of the Monkeypox Test Policy
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Monkeypox Serology Tests

 Not used to diagnose, or aid in the diagnosis of, an active infection

 Not tests of immunity

 May further understanding of the disease process

FDA does not intend to object to the use of monkeypox tests developed and 

performed in a high-complexity CLIA-certified laboratory that is part of an entity 

that conducts research on diseases and is integrated into the direct medical care 

of the patient (often referred to as academic medical center laboratories) where:

• the laboratory notifies FDA of validation, and

• certain information is included in the test reports.

*Details in Section IV.C of the Monkeypox Test Policy
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First Monkeypox EUA

Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR

www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypoxemergency-use-authorizations-medical-devices#molecular

• Intended to detect monkeypox and other non-variola 

Orthopoxvirus DNA using lesion swab specimens
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Resources for Monkeypox Test 

Development and Validation

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

• Subscribe to CDRH Email Lists: www.fda.gov/about-fda/center-devices-and-radiologicalhealth/subscribe-cdrh-mailing-lists

– Monkeypox and Medical Devices

– In Vitro Diagnostics

• For questions about Monkeypox 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-useauthorizations-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-healthemergency
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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, Slides and Transcript will be available at:

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

• Section “Specialty Technical Topics”

• Sub-Section “Public Health Emergencies”

• If you have additional questions about monkeypox:

• Email: MPXDx@fda.hhs.gov

• Upcoming Webinars:

• www.fda.gov/CDRHWebinar

Next Virtual Town Hall 

September 21, 2022 from 12:05 – 1 PM ET