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 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received McLeroy, Kiley 0595 Comment from CPAC Foundations Center for Regulatory Freedom 2025.pdf CPAC Foundation Center for Regulatory Freedom Other -- Submitted Electronically Simple 09/11/2025 09/11/2025