ICR Documents

Supporting Statement A

Document	Date Uploaded
0910-0595_Supporting Statement A_2025.docx	12/03/2025

Supporting Statement B

Document	Date Uploaded

Supplementary Documents

Title	Document	Document Type	Date Uploaded
CDER Therapeutics Fact Sheet Template - Healthcare Provider Fact Sheet Template	0910-0595_CDER_eua_healthcare_provider_fact_sheet_template.docx	Supplementary Document	12/02/2025
CDER Therapeutics Fact Sheet Templates - Patient, Parent, and Caregiver Fact Sheet Template	0910-0595_CDER_eua_patient_parent_and_caregiver_fact_sheet_template.docx	Supplementary Document	12/02/2025
CDRH COVID-19 Diagnostic Templates (Molecular and Antigen) - Molecular Diagnostic EUA Cover Sheet Template	0910-0595_CDRH_Molecular-Cover-Sheet.docx	Supplementary Document	12/02/2025
CDRH COVID-19 Diagnostic Templates (Molecular and Antigen) - Molecular Diagnostic Template	0910-0595_CDRH_molecular_template2.docx	Supplementary Document	12/02/2025
CDRH COVID-19 Diagnostic Templates (Molecular and Antigen) -Molecular Diagnostic Home Specimen Collection Template	0910-0595_CDRH_molecular_homecollection_template2.docx	Supplementary Document	12/02/2025
CDRH COVID-19 Diagnostic Templates (Molecular and Antigen) - Antigen Diagnostic Template	0910-0595_CDRH_antigen_template.docx	Supplementary Document	12/02/2025
CDRH COVID-19 Diagnostic Templates (Molecular and Antigen) - Molecular and Antigen Home Use Test Template	0910-0595_CDRH_Molecular-and-Antigen-Home-Use-Test-Template.docx	Supplementary Document	12/02/2025
CDRH COVID-19 Diagnostic Templates (Molecular and Antigen) - Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing	0910-0595_CDRH_SupplementalTemplate-Molecular-Antigen-Diagnostic-COVID-19-Tests-Screening-Serial-Testing.docx	Supplementary Document	12/02/2025
CDRH COVID-19 Serology/Antibody Templates - Serology Template	0910-0595_CDRH_serology-template.docx	Supplementary Document	12/02/2025
CDRH COVID-19 Serology/Antibody Templates - Template for Serology Tests that Detect or Correlate to Neutralizing Antibodies	serology-neutralizing-template.docx	Supplementary Document	12/02/2025
CDRH COVID-19: Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 Templates - Appendix J - Sample Updated Fact Sheet for Health Care Providers	Pooling and Serial Testing Amendment - Appendix J - Sample Updated Fact Sheet for Health Care Providers.pdf	Supplementary Document	12/02/2025
CDRH COVID-19: Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 Templates - Appendix K - Sample Updated Fact Sheet for Patients	Pooling and Serial Testing Amendment - Appendix J - Sample Updated Fact Sheet for Health Care Providers.pdf	Supplementary Document	12/02/2025
CDRH COVID-19: Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing Templates - Appendix L - Fact Sheet for Health Care Providers (Template)	0910-0595_CDRH_EUA-Molecular-Serial-Umbrella-HCP-Fact-Sheet-Template (1).docx	Supplementary Document	12/02/2025
CDRH COVID-19: Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing Templates - Appendix M - Fact Sheet for Patients (Template)	0910-0595_CDRH_EUA-Molecular-Serial-Umbrella-Patient-Fact-Sheet-Template.docx	Supplementary Document	12/02/2025
CDRH COVID-19: Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing Templates - Appendix N - Test Summary (Template)	0910-0595_CDRH_EUA-Molecular-Serial-Umbrella-Test-Summary-Template (2).docx	Supplementary Document	12/02/2025
CDRH COVID-19: EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests Templates - Fact Sheet for Healthcare Pro	0910-0595_CDRH_HCP Fact Sheet.pdf	Supplementary Document	12/03/2025
CDRH COVID-19: EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests Templates - Fact Sheet for Patients	EUA-LDT-patients_0.pdf	Supplementary Document	12/03/2025
CDRH Mpox Templates and EUA Summary Templates (Molecular and Antigen) - EUA Summary Template for Developers of Molecular Diagnostic Tests for Monkeypox	0910-0595_CDRH_Summary_EUA_Template_Monkeypox.docx	Supplementary Document	12/03/2025
CDRH Mpox Templates and EUA Summary Templates (Molecular and Antigen) - EUA Template for Developers of Molecular Diagnostic Tests for Monkeypox	0910_0595_CDRH_EUA_Template_Monkeypox (2).docx	Supplementary Document	12/03/2025
CDRH Mpox Templates and EUA Summary Templates (Molecular and Antigen) - EUA Summary Template for Developers of Antigen Diagnostic Tests for Monkeypox	Summary-EUA-Antigen-Template-Monkeypox (1).docx	Supplementary Document	12/03/2025
CDRH Mpox Templates and EUA Summary Templates (Molecular and Antigen) - EUA Template for Developers of Antigen Diagnostic Tests for Monkeypox	0910-0595_CDRH_EUA-Antigen-Monkeypox-Template.docx	Supplementary Document	12/03/2025
CDRH Other Devices Templates - Ventilator EUA Interactive Review Template	0910-0595_CDRH_Ventilator-EUA-Interactive-Review-Template.docx	Supplementary Document	12/03/2025

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