November 25, 2022

• Revised Emergency Use Authorization
  • DxLab COVID-19 Test (DxLab Inc.)

November 23, 2022

• Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (Monkeypox and COVID-19) - November 30, 2022
• Class I Recall: Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment 

November 22, 2022

• New Emergency Use Authorizations
  • CorDx COVID-19 Ag Test (CorDx, Inc.)
  • Fastep COVID-19 Antigen Home Test (Azure Biotech Inc.)
  • Lucira COVID-19 & Flu Test (Lucira Health, Inc.)
• Updated Emergency Use Authorizations
  • BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
  • Verily COVID-19 RT-PCR Test (Verily Life Sciences)
• Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
• FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls (Updated)
• At-Home OTC COVID-19 Diagnostic Tests (Updated)

November 21, 2022

• New Emergency Use Authorization
  • Diversified Medical Healthcare SARS-CoV-2 Assay (Premier Medical Laboratory Services)
• Updated Emergency Use Authorization
  • Flowflex COVID-19 Antigen Home Test (ACON Laboratories, Inc)
  • Hotgen COVID-19 Antigen Home Test (Beijing Hotgen Biotech Co., Ltd.)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190020, DEN190056, DEN200059, DEN210003, and DEN210013 added)

November 18, 2022

• New Emergency Use Authorization
  • Hotgen COVID-19 Antigen Home Test (Beijing Hotgen Biotech Co., Ltd.)
• At-Home OTC COVID-19 Diagnostic Tests (Updated)
• Automated External Defibrillators (AEDs) (Updated)
• Monkeypox and Medical Devices (Updated)
• Hearing Aids (Updated)

November 17, 2022

• New Emergency Use Authorization
  • NIDS COVID-19 Antigen Home Test (ANP Technologies, Inc.)
• At-Home OTC COVID-19 Diagnostic Tests (Updated)
• At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative Results: FDA Safety Communication (Updated)
• At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
• Legacy Identification Number (NDC/NHRIC): Frequently Asked Questions (Updated)
• MDUFA IV Performance Report - November 16, 2022
• October 2022 Device Approval List
• Automated External Defibrillators (AEDs) (Updated)
• Medtronic HeartWare Ventricular Assist Device (HVAD) System (Updated)
• Summary Minutes for October 26-27, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
• Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (Updated)
• FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls (Updated)

November 16, 2022

• Updated Emergency Use Authorizations
  • RealStar SARS-CoV02 RT-PCR Kits U.S. (altona Diagnostics GmbH)
  • Lucira COVID-19 All-In-One Test Kit (Lucira Health, Inc.)
• Class I Recall - Insulet Recalls Omnipod DASH Insulin Management System's Personal Diabetes Manager (PDM)

November 15, 2022

• New Emergency Use Authorization
  • cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (Roche Molecular Systems, Inc.)
• Cybersecurity (Updated)
• Public Workshop - Appropriate Use of Consensus Standards, Dec. 7, 2022
• Standards and Conformity Assessment Program (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190031, DEN190042, DEN200006, DEN200018, DEN200042, and DEN200044 added)

November 14, 2022

• Voluntary eSTAR Program (Updated)
• Monkeypox and Medical Devices (Updated)

November 10, 2022

• Revised Emergency Use Authorizations
  • UOL COVID-19 Test (Uh-Oh Labs Inc.)
  • Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit (Thermo Fisher Scientific Inc.)
• Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents - Guidance for Industry and Food and Drug Administration Staff
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• CDRH Petitions (Updated)
• Federal Register: Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents

November 9, 2022

• New Emergency Use Authorization
  • The Nano Test for COVID-19 (Nanobiosym Precision Testing Services)
• Updated Emergency Use Authorizations
  • Xpert Xpress CoV-2 plus (Cepheid)

November 8, 2022

• New Emergency Use Authorization
  • Rize Laboratory SARS nCoV-2019 Multiplexed Assay (Rize Laboratory)
• Meeting Materials for November 10, 2022 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting

November 7, 2022

• Updated Emergency Use Authorizations
  • Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
  • Celltrion DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
• Summary Minutes: October 20, 2022 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting
• 24 Hour Summary and Presentations: November 1, 2022  Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting
• Pulse Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200005 and DEN210014 added)
• CDRH Statement: CDRH Hosts Workshop in Partnership with NIH, Continues Commitment to Advance Medical Device Innovation to Help Mitigate Opioid Crisis
• CDRH Petitions (Updated)

November 4, 2022

• Revised Emergency Use Authorizations
  • Pixel by LabCorp COVID-19 Test Home Collection Kit (Laboratory Corporation of America (LabCorp))
  • BioGX Xfree COVID-19 Direct RT-PCR (BioGX, Inc.)
• Updated Emergency Use Authorizations
  • OPTI SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.)
  • PhoenixDx SARS-CoV-2 Multiplex (Trax Management Services Inc.)
• Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (Monkeypox and COVID-19) - November 9, 2022
• Activities to Support Medical Device Innovators (Updated)
• Federal Register: Postmarket Surveillance of Medical Devices

November 3, 2022

• CDRH Petitions (Updated)
• Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication
• CDRH Learn (Updated)
  • Specialty Technical Topics - Presentation and Transcript: Clinical Decision Support Software Final Guidance - October 18, 2022
  • In Vitro Diagnostics - Presentation and Transcript: COVID-19 and and Monkeypox Test Development and Validation Virtual Town Hall Series - October 26, 2022

November 2, 2022

• Monkeypox and Medical Devices (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220024 added)

November 1, 2022

• MQSA National Statistics (Updated)
• In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 (Updated)
• Class I Recall: Teleflex Recalls Iso-Gard Filter S for Risk of Splitting or Detaching That May Cause Leakage and Insufficient Air Supply to Patients
• 24 Hour Summary and Presentations for October 26-27, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting
• Federal Register: Testing Communications by the Food and Drug Administration's Center for Devices and Radiological Health

October 31, 2022

• Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage - Letter to Health Care Providers
• Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage: FDA Safety Communication
• Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
• MedSun Newsletter - November 2022

October 28, 2022

• COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care - Letter to Health Care Providers (Updated)
• Meeting Materials for November 1, 2022 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
• Virtual Public Workshop - CDRH Industry Basics: Understanding Risk with Medical Devices - November 15, 2022
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200046, DEN210024 and DEN210034 added)
• Breakthrough Devices Program (Updated)

October 27, 2022

• Revised Emergency Use Authorizations
  • cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)
  • cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems, Inc.)
• Updated Emergency Use Authorizations
  • Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.)
  • Atellica IM SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics, Inc.)
  • ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics, Inc.)
  • Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit (Bio-Rad Laboratories, Inc.)
  • TaqPath COVID-19 RNase P Combo Kit 2.0 (Thermo Fisher Scientific Inc.)
• Third Party Review Organization Performance Report - FY2022, Q4
• Digital Health Research and Partnerships

October 26, 2022

• Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions - Guidance for Industry and Food and Drug Administration Staff (Updated)
• Table of Pharmacogenetic Associations (Updated)

October 25, 2022

• Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication
• 24 Hour Summary and Presentations for October 20, 2022 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting 

October 24, 2022

• Consumer Information on: PATHWAY anti-HER2/neu Rabbit Monoclonal Primary Antibody - P990081/S047 (Ventana Medical Systems, Inc.)
• Consumer Information on: Oncomine Dx Target Test - P160045/S031 (Life Technologies Corporation)
• Meeting Materials: October 26-27, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
• At-Home OTC COVID-19 Diagnostic Tests (Updated)

October 21, 2022

• Updated Emergency Use Authorizations
  • iHealth COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)

October 20, 2022

• Updated Emergency Use Authorizations
  • SelfCheck cobas SARS-CoV-2 Assay (Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute)
  • NxTAG CoV Extended Panel Assay (Luminex Molecular Diagnostics, Inc.)
  • CareStart COVID-19 Antigen Home Test (Access Bio, Inc.)
• Revoked Emergency Use Authorizations
  • Cleveland Clinic SARS-CoV-2 Assay (Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute)
  • SelfCheck COVID-19 TaqPath Multiplex PCR (Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute)
• Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care - Draft Guidance for Industry and Food and Drug Administration Staff
• Consumer Information on: LungFit PH - P200044 (Beyond Air, Inc.)
• FDA Provides Lists of Laboratories Offering Notified Laboratory-Developed Monkeypox Tests

October 19, 2022

• Revised Emergency Use Authorization
  • Rapid SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
• Legacy Identification Number (NDC/NHRIC): Frequently Asked Questions
• UPC Alternatives UDI-A160001 and UDI-A160002: Frequently Asked Questions
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200050 and DEN200069 added)

October 18, 2022

• New Emergency Use Authorization
  • Metrix COVID-19 Test (Aptitude Medical Systems Inc.)
• Revised Emergency Use Authorization
  • Pilot COVID-19 At-Home Test (SD Biosensor, Inc.)
• CDRH Proposed Guidance Development
• CDRH Proposed Guidances for Fiscal Year 2023 (FY2023)
• Meeting Materials for October 20, 2022 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

October 17, 2022

• Medtronic HeartWare Ventricular Assist Device (HVAD) System (Updated)
• FDA's Activities: Urogynecologic Surgical Mesh (Updated)
• Printable Slides: Webinar - Clinical Decision Support Software Final Guidance - October 18, 2022 
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200046 and DEN210027 added)

October 14, 2022

• Updated Emergency Use Authorization
  • CLINITEST Rapid COVID-19 Antigen Self-Test (Siemens Healthineers)

October 13, 2022

• Updated Emergency Use Authorizations
  • NeoPlex COVID-19 Detection Kit (GeneMatrix, Inc.)
  • Xpert Xpress SARS-CoV-2 DoD (Cepheid)
  • AvellinoCoV2 test (Avellino Lab USA, Inc.)
• PASCAL Precision Transcatheter Valve Repair System - P220003 (Edward Lifesciences, LLC)
• Webinar - Computer Software Assurance for Production and Quality System Software Draft Guidance - October 27, 2022
• Federal Register: Request for Nominations for Individuals and Consumer Organizations for Advisory Committees

October 12, 2022

• Class I Recall: Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210005 added)
• MedSun Newsletters (October 2022)

October 11, 2022

• CDRH Statement: CDRH Launches the Total Product Life Cycle Advisory Program Pilot
• Cybersecurity: Tips for Clinicians - Keeping Your Patients’ Connected Medical Devices Safe 

October 7, 2022

• New Emergency Use Authorization
  • Alinity m MPXV (Abbott Molecular, Inc.)
• Revised Emergency Use Authorization
  • Quest COVID-19 PCR DTC (Quest Diagnostics Nichols Institute)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• November 10, 2022: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
• LASIK (Updated)
• Federal Register: Guidance: Laser-Assisted In Situ Keratomileusis Lasers--Patient Labeling Recommendations

October 6, 2022

• Updated Emergency Use Authorizations
  • ID NOW Covid-19 2.0 (Abbott Diagnostics Scarborough)
  • Clip COVID Rapid Antigen Test (Luminostics, Inc.)
  • Rapid SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
  • OHC COVID-19 Antigen Self Test (OSANG LLC)
  • Speedy Swab Rapid COVID-19 Antigen Self-Test (Watmind USA)
• FDA Activities Related to Essure (Updated)
• Information for Patients and Health Care Providers: Essure (Updated)
• October 26-27, 2022: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff
• 522 Postmarket Surveillance Studies Program (Updated)
• Procedures for Handling Post-Approval Studies Imposed by PMA Order - Guidance for Industry and Food and Drug Administration Staff
• Post-Approval Studies Program (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200017 and DEN200041 added)

October 5, 2022

• Medical Device User Fee Amendments (MDUFA) | FDA
• Device Registration and Listing | FDA
• User Fees and Refunds for De Novo Classification Requests
• User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications
• User Fees and Refunds for Premarket Notification Submissions (510(k)s)
• User Fees and Refunds for 513(g) Requests for Information
• Aptima CMV Quant Assay (Hologic, Inc.) - P210029
• At-Home OTC COVID-19 Diagnostic Tests (Extended Expiration Date for QuickVue At-Home OTC COVID-19 Test)
• Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (Updated)
• MQSA National Statistics (Updated)

October 4, 2022

• Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories (Updated)
• Transcript, Presentation, and Slides: COVID-19 and and Monkeypox Test Development and Validation Virtual Town Hall Series - September 28, 2022

October 3, 2022

• IC-8 Apthera Intraocular Lens (AcuFocus, Inc.) - P210005
• Updated Emergency Use Authorization
  • Lyra SARS-CoV-2 Assay (Quidel Corporation)
• eCopy Medical Device Submissions (Updated)
• Send and Track Medical Device Premarket Submissions Online: CDRH Portal (Updated)
• Voluntary eSTAR Program (Updated)
• FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals
• FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals
• FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals

September 30, 2022

• LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure
• Medical Devices and Radiation-Emitting Products Committee Vacancies (Updated)
• Roster for the Ophthalmic Devices Panel (Updated)
• Roster of the Immunology Devices Panel (Updated)
• Roster of the Medical Devices Dispute Resolution Panel (Updated)
• Roster of the Anesthesiology and Respiratory Therapy Devices Panel (Updated)

September 29, 2022

• Virtual Town Hall Series - Test Development and Validation (COVID-19 and Monkeypox) - September 28, 2022 (Updated)
• Joint Public Workshops - Medical Devices for Opioid Use
• NeVa VS - H210004 (Versalio)
• Oncomine Dx Target Test - P160045/S035
• Revised Emergency Use Authorization
  • SCoV-2 Ag Detect Rapid Self-Test (InBios International Inc.)
• Device Software Functions Including Mobile Medical Applications (Updated)
• Examples of Device Software Functions the FDA Regulates (Updated)
• Examples of Software Functions That Are NOT Medical Devices (Updated)
• Examples of Software Functions for Which the FDA Will Exercise Enforcement Discretion (Updated)
• How to Determine if Your Product is a Medical Device (Updated)
• Digital Health Terms (Updated)
• Ask a Question About Digital Health Regulatory Policies (Updated)

September 28, 2022

• Revised Emergency Use Authorization
  • QuickVue At-Home OTC COVID-19 Test (Quidel Corporation)
• Catalog of Regulatory Science Tools to Help Assess New Medical Devices
• Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration - 10/24/2022 (Updated)
• CDRH Learn: Specialty Technical Topics (Updated)
  • Presentation and Transcript: Policy for Monkeypox Tests, Session 2 - September 21, 2022

September 27, 2022

• Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Guidance for Developers and Food and Drug Administration Staff
• COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2 (Updated)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Testing for SARS-CoV-2 (Updated)
• COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
• Webinar - Clinical Decision Support Software Final Guidance - October 18, 2022
• Clinical Decision Support Software - Guidance for Industry and Food and Drug Administration Staff
  • Graphic:  Your Clinical Decision Support Software: Is It a Medical Device?
• Digital Health Policy Navigator
• Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (Updated)
• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff (Updated)
• Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff (Updated)
• Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions (Updated)
• Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff (Updated)
• List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
• Federal Register: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Amendment of Notice
• Federal Register: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
• Federal Register: Guidance - Clinical Decision Support Software

September 26, 2022

• Digital Health Software Precertification (Pre-Cert) Pilot Program

September 23, 2022

• Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Federal Register: Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and Institutional Review Boards; Availability

September 22, 2022

• Revoked Emergency Use Authorization
  • Laboratorio Clinico Toledo SARS-CoV-2 Assay (Laboratorio Clinico Toledo)
• Revised Emergency Use Authorization
  • TaqPath COVID-19 RNase P Combo Kit 2.0 (Thermo Fisher Scientific Inc.)
• Virtual Town Hall Series - Test Development and Validation (COVID-19 and Monkeypox) - September 28, 2022

September 21, 2022

• Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff
• eCopy Program for Medical Device Submissions (Updated)
• Tracking Your Premarket Submission's Progress (Progress Tracker) (Updated)
• Office of Product Evaluation and Quality (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220025 added)

September 20, 2022

• Information on Cybersecurity (Updated)
• Medical Device Development Tools (MDDT) (Updated)

September 19, 2022

• Virtual Town Hall Series - Monkeypox Test Development and Validation (Updated)
• CDRH Learn: Specialty Technical Topics (Updated)  
  • Presentation and Transcript: Monkeypox Test Development and Validation Webinar - September 14, 2022

September 16, 2022

• Revised Emergency Use Authorization
  • LumiraDx SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
  • Lyra SARS-CoV-2 Assay (Quidel Corporation) 
• ASCA-Accredited Testing Laboratories (Updated)
• Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers

September 15, 2022

• Re-issued Emergency Use Athorizations
  • Quest Diagnostics Monkeypox Virus Qualitative Real-Time PC (Quest Diagnostics Nichols Institute) 
• Class I Recall: Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances
• Pulse Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
• Meeting Notice: November 1, 2022 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee

September 14, 2022

• Re-issued Emergency Use Authorizations
  • Predicine SARS-CoV-2 RT-PCR Test (Predicine, Inc.)
  • Rheonix COVID-19 MDx Assay (Rheonix, Inc.)
• Presentation and Transcript: Monkeypox Test Development and Validation Webinar - September 14, 2022

September 16, 2022

• Revised Emergency Use Authorization
  • LumiraDx SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
  • Lyra SARS-CoV-2 Assay (Quidel Corporation)
• ASCA-Accredited Testing Laboratories (Updated)
• Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers

September 15, 2022

• Re-issued Emergency Use Athorizations
  • Quest Diagnostics Monkeypox Virus Qualitative Real-Time PC (Quest Diagnostics Nichols Institute) 
• Class I Recall: Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances
• Pulse Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
• Meeting Notice: November 1, 2022 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee

September 14, 2022

• Re-issued Emergency Use Authorizations
  • Predicine SARS-CoV-2 RT-PCR Test (Predicine, Inc.)

September 7, 2022

• New Emergency Use Authorization
  • Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR
• Monkeypox and Medical Devices
• Monkeypox Emergency Use Authorizations for Medical Devices
• Policy for Monkeypox Tests to Address the Public Health Emergency - Guidance for Laboratories, Commercial Manufacturers and Food and Drug Administration Staff
• Summary Minutes: July 12-13, 2022 Patient Engagement Advisory Committee Meeting 

September 6, 2022

• Revised Emergency Use Authorization
  • TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
  • Rapid SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
  • Flowflex COVID-19 Antigen Home Test (ACON Laboratories, Inc.)
  • LumiraDx SARS-CoV-2 Ab Test (LumiraDx UK Ltd.)
• Updated Emergency Use Authorization
  • SARS-CoV-2 real time RT-PCR test (Authorized by HHS/OASH) (University of Louisville Infectious Diseases Laboratory)
• Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
• Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: Letter to Health Care Providers
• Personal Protective Equipment EUAs (Updated)
• Mammography Facility Adverse Event and Action Report – September 6, 2022: Memorial MRI & Diagnostic, LLC
• Mammography Facility Adverse Event and Action Report – September 6, 2022: Ste. Genevieve County Memorial Hospital

September 2, 2022

• Transcript and Presentation: Coronavirus (COVID-19) Test Development and Validation Virtual Town Hall Series - August 24, 2022