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
EMERGENCY USE AUTHORIZATION – FD&C SECTION 564 EUA CATEGORIES In Vitro Diagnostic Products High Complexity Molecular-Based Laboratory Developed Tests RECENT FINAL MEDICAL Personal Protective Equipment and DEVICE GUIDANCE Decontamination Systems DOCUMENTS RELATED TO Ventilators and Other Medical Devices COVID-19 PUBLIC HEALTH EMERGENCY Therapeutics https://www.fda.gov/medical-devices/guidance- documents-medical-devices-and-radiation-emitting- products/recent-final-medical-device-guidance- documents
BACKGROUND - FDA EMERGENCY USE AUTHORIZATION February 4 th 2020, Alex AZAR (HHS Secretary) issued Determination of Public Health Emergency https://www.fda.gov/media/135010/download
COVID-19 DIAGNOSTIC TEST GUIDANCE DOCUMENT Validation Notification Distribution EUA Request Submission https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public- health-emergency
VALIDATION RECOMMENDATIONS Serological Molecular Limit of Detection Cross-reactivity Clinical Evaluation Class Specificity Recommended Clinical Agreement Study Inclusivity Validation Studies CDRH-OIR-POPS@fda.hhs.gov Cross Reactivity Antigen Limit of Detection Cross-reactivity Clinical Agreement https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public- health-emergency
NOTIFICATION CDRH-EUA-Templates@FDA.HHS.GOV Molecular Test Serological Test Notification Notification (Non EUA Pathway) Validation is complete, intent to Subject: Antibody Test Notification distribute Validation is complete, intent to Name of the Manufacturer distribute Address Name of the Manufacturer Contact person Address Instructions for Use Contact person Summary of Assay Performance Instructions for Use Summary of Assay Performance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public- health-emergency
DISTRIBUTION Molecular Test Serological Test Notification Notification (Non EUA Pathway) Following FDA acknowledgment Serological tests witsh infection claims molecular diagnostic manufactures cannot distribute their tests until can distribute their tests authorization is received EUA request submission required 15 Serological tests with qualitative detection business after notification claims can distribute their tests Following FDA acknowledgement of notification Labeling and assay performance must Registration and listing, (required for be posted on company website importation) Product Code: QKO Submission Number: Enforcement Required limitation statements added to labeling
EUA REQUEST SUBMISSION EUA Request Submission Contents Device Description Test principle and procedure • Labeling (IFU, Health Care and Patient Fact Sheets • Request submission using Manufacturing and Distribution Information EUA template Units manufactured per week Distribution plan with list of all current distributors Reagent stability information with a cover letter and Performance Evaluation FDA form 3514 Validation study protocols and reports •
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
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