SLIDE 1
Navigating Emergency Use Authorization: FDA Policy for COVID- 19 Diagnostic Tests
Ian McGill, PSM, ASQ CBA April 2020
AGENDA
- EUA Background
- COVID-19 Policy Guidance Document
- Test Type and Pathways to distribution
- Key Resources
Navigating Emergency Use Authorization: FDA Policy for COVID- 19 - - PowerPoint PPT Presentation
Navigating Emergency Use Authorization: FDA Policy for COVID- 19 - - PowerPoint PPT Presentation
Navigating Emergency Use Authorization: FDA Policy for COVID- 19 Diagnostic Tests Ian McGill, PSM, ASQ CBA April 2020 AGENDA EUA Background COVID-19 Policy Guidance Document Test Type and Pathways to distribution Key
SLIDE 2
SLIDE 3
EMERGENCY USE AUTHORIZATION – FD&C SECTION 564
EUA CATEGORIES In Vitro Diagnostic Products Therapeutics High Complexity Molecular-Based Laboratory Developed Tests Personal Protective Equipment and Decontamination Systems Ventilators and Other Medical Devices
RECENT FINAL MEDICAL DEVICE GUIDANCE DOCUMENTS RELATED TO COVID-19 PUBLIC HEALTH EMERGENCY
https://www.fda.gov/medical-devices/guidance- documents-medical-devices-and-radiation-emitting- products/recent-final-medical-device-guidance- documents
SLIDE 4
BACKGROUND - FDA EMERGENCY USE AUTHORIZATION
https://www.fda.gov/media/135010/download
February 4th 2020, Alex AZAR (HHS Secretary) issued Determination of Public Health Emergency
SLIDE 5
COVID-19 DIAGNOSTIC TEST GUIDANCE DOCUMENT
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public- health-emergency
Validation Notification Distribution EUA Request Submission
SLIDE 6
VALIDATION RECOMMENDATIONS
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public- health-emergency
Limit of Detection
Clinical Evaluation
Inclusivity Cross Reactivity
Molecular Serological
Clinical Agreement Cross-reactivity Class Specificity Clinical Agreement Study
Antigen
Limit of Detection Cross-reactivity Recommended Validation Studies
CDRH-OIR-POPS@fda.hhs.gov
SLIDE 7
NOTIFICATION CDRH-EUA-Templates@FDA.HHS.GOV
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public- health-emergency
Molecular Test Notification
Validation is complete, intent to distribute Name of the Manufacturer Address Contact person Instructions for Use Summary of Assay Performance
Serological Test Notification (Non EUA Pathway)
Validation is complete, intent to distribute Name of the Manufacturer Address Contact person Instructions for Use Summary of Assay Performance Subject: Antibody Test Notification
SLIDE 8
DISTRIBUTION
Molecular Test Notification
Following FDA acknowledgment molecular diagnostic manufactures can distribute their tests EUA request submission required 15 business after notification Labeling and assay performance must be posted on company website
Serological Test Notification (Non EUA Pathway)
Serological tests with qualitative detection claims can distribute their tests Following
- FDA acknowledgement of notification
- Registration and listing, (required for
importation)
- Product Code: QKO
- Submission Number: Enforcement
- Required limitation statements added to
labeling
Serological tests witsh infection claims cannot distribute their tests until authorization is received
SLIDE 9
EUA REQUEST SUBMISSION
Request submission using EUA template with a cover letter and FDA form 3514
Device Description
- Test principle and procedure
- Labeling (IFU, Health Care and Patient Fact Sheets
Manufacturing and Distribution Information
- Units manufactured per week
- Distribution plan with list of all current distributors
- Reagent stability information
Performance Evaluation
- Validation study protocols and reports
EUA Request Submission Contents
SLIDE 10
ADDITIONAL RESOURCES
Frequently Asked Questions
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2
FDA Town Hall Series
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-town-hall-series-immediately-effect- guidance-coronavirus-covid-19-diagnostic-tests-04222020?utm_source=CDRHTwitterD
FDA Hotline
1-888-INFO-FDA, select option* CDRH-EUA-Templates@FDA.HHS.GOV.
Authorized Tests
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.
Listed Tests
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm Pre-EUA CDRH-EUA-Templates@FDA.HHS.GOV
Template
Test Kit Manufacturer: EUA Template
SLIDE 11