January 27, 2023

• Monkeypox (mpox) and Medical Devices (Updated)
• Health Canada and FDA eSTAR Pilot (Updated)
• Class I Recall: LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure
• Federal Register: Premarket Approval of Medical Devices

January 26, 2023

• CDRH 2022 Annual Report
• Class I Recall: Emergent Recalls Certain RSDL (Reactive Skin Decontamination Lotion) Kits Due to Leak Potential

January 25, 2023

• GUDID Data Trends (Updated)
• Class I Recall: Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump Through Damaged Balloon Catheter, Causing Patient Harm

January 24, 2023

• Reissued Emergency Use Authorizations
  • QuickVue At-Home OTC COVID-19 Test (Quidel Corporation)
  • InteliSwab COVID-19 Rapid Test Rx (OraSure Technologies, Inc.)
• Revised Emergency Use Authorizations
  • CareStart COVID-19 Antigen Test (Access Bio, Inc.)
  • InteliSwab COVID-19 Rapid Test Pro (OraSure Technologies, Inc.)
  • Celltrion DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
  • Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
  • Speedy Swab Rapid COVID-19 Antigen Self-Test (Watmind USA)
  • cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
• CDRH Petitions (Updated)
• At-Home OTC COVID-19 Diagnostic Tests (Updated)
• For Consumer information:  Agilent Resolution CtDX FIRST - P210040
• Transcript: October 26-27, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting

January 23, 2023

• Federal Register: Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee

January 20, 2023

• Medtronic HeartWare Ventricular Assist Device (HVAD) System (Updated)
• Recalls Related to the HVAD System (Updated)

January 19, 2023

• At-Home OTC COVID-19 Diagnostic Tests (Updated)
• CDRH Learn (Updated)
  • Presentation, Transcript and Printable Slides:  Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkeypox (mpox) and COVID-19 - January 11, 2023
• Federal Register: Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions
• Federal Register: Ophthalmic Devices; Classification of the Intense Pulsed Light Device for Managing Dry Eye
• Federal Register: Records and Reports for Radiation Emitting Electronic Products; Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products

January 18, 2023

• FDA Seeks Public Comment: Advancing Real-World Data and Real-World Evidence with User Fee Funding (MDUFA V)
• Federal Register: Adverse Event Program for Medical Devices (Medical Product Safety Network)

January 17, 2023

• Reissued Emergency Use Authorizations
  • BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
  • InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.)
• Updated Emergency Use Authorization
  • Pilot COVID-19 At-Home Test (SD Biosensor, Inc.)

January 13, 2023

• ASCA-Recognized Accreditation Bodies (Updated)
• At-Home OTC COVID-19 Diagnostic Tests (Updated)
• Federal Register: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Liver Related Disease Progression

January 12, 2023

• New Emergency Use Authorization
  • Scope Molecular Laboratory SARS nCoV-2019 Multiplexed Assay (Scope Molecular Laboratory)
• Revised Emergency Use Authorizations
  • iHealth COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)
• Webinar:  Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices, February 2, 2023
• Policy for Coronavirus Disease-2019 Tests (Revised) - Guidance for Developers and Food and Drug Administration Staff
• Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised) - Guidance for Test Developers and Food and Drug Administration Staff
• Hearing Aids (Updated)
• Federal Register: Neurological Devices; Classification of the Digital Therapy Device to Reduce Sleep Disturbance for Psychiatric Conditions

January 11, 2023

• New Emergency Use Authorization
  • QuantiVirus MPXV Test Kit (DiaCarta, Inc.)
• Updated Emergency Use Authorizations
  • MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
  • SCoV-2 Ag Detect Rapid Self-Test (InBios International Inc.)
• Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
• Federal Register: Photobiomodulation Devices--Premarket Notification Submissions

January 5, 2023

• Revoked Emergency Use Authorization
  • HDPCR SARS-CoV-2 Assay (ChromaCode Inc.)
• Federal Register: Cardiovascular Devices: Classification of the Hardware and Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate
• Federal Register: Ear, Nose, and Throat Devices: Classification of the Powered Insertion System for a Cochlear Implant Electrode Array
• Federal Register: Orthopedic Devices: Classification of the Resorbable Shoulder Spacer
• Federal Register: Physical Medicine Devices: Classification of the Electroencephalography-Driven Upper Extremity Powered Exerciser
• Federal Register: Physical Medicine Devices: Classification of the Virtual Reality Behavioral Therapy Device for Pain Relief

January 4, 2023

• Federal Register: Neurological Devices; Classification of the Brain Stimulation Programming Planning Software
• Federal Register: Orthopedic Devices; Classification of the Bone Indentation Device
• Federal Register: Orthopedic Devices; Classification of the Implantable Post-Surgical Kinematic Measurement Knee Device

January 3, 2023

• MQSA National Statistics (Updated)

December 30, 2022

• Federal Register: Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System

December 29, 2022

• Updated Emergency Use Authorizations
  • BinaxNOW COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
  • iHealth COVID-19 Antigen Rapid Test Pro  (iHealth Labs, Inc.)
• Revised Emergency Use Authorizations
  • INDICAID COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
• Total Product Life Cycle Advisory Program (TAP) (Updated)
• Federal Register: Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid
• Federal Register: Emergency Use Authorization: In Vitro Diagnostic Device in Response to an Outbreak of Mpox

December 28, 2022

• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
• Federal Register: Cardiovascular Devices; Classification of the Extracorporeal System for Carbon Dioxide Removal
• Federal Register: Orthopedic Devices; Classification of the Resorbable Implant for Anterior Cruciate Ligament Repair

December 27, 2022

• New Emergency Use Authorizations
  • VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System (Becton, Dickinson & Company (BD))
  • Visby Medical Respiratory Health Test (Visby Medical, Inc.)
• Updated Emergency Use Authorizations
  • Rapid SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
  • BinaxNOW COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
  • INDICAID COVID-19 Rapid Antigen At-Home Test (PHASE Scientific International, Ltd.)
  • SCoV-2 Ag Detect Rapid Test (InBios International, Inc.)
  • SCoV-2 Ag Detect Rapid Self-Test (InBios International, Inc.)
• MedSun Newsletter - January 2023
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220017 added)
• Federal Register: Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device

December 23, 2022

• FAQs on Viral Transport Media During COVID-19 (Updated)
• Federal Register: Cardiovascular Devices; Classification of the Adjunctive Hemodynamic Indicator with Decision Point

December 22, 2022

• New Emergency Use Authorizations
  • ASSURE-100 Rapid COVID-19 Home Test (Oceanit Foundry LLC)
  • Advin COVID-19 Antigen Test @Home (Advin Biotech Inc.)
• At-Home OTC COVID-19 Diagnostic Tests (Updated)
• Consumer Information on: Magtrace and Sentimag Magnetic Localization System - P160053/S002
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190029, DEN190032, DEN190047, and DEN200064 added)
• Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris: FDA Safety Communication

December 21, 2022

• New Emergency Use Authorizations
  • ImmuView COVID-19 Antigen Home Test (CTK Biotech, Inc.)
  • Hi-Sense COVID-19 Molecular Testing Kit 1.0 (OnsiteGene, Inc.)
• Updated Emergency Use Authorizations
  • 1copy COVID-19 qPCR Multi Kit (1drop Inc.)
  • CorDx COVID-19 Ag Test (CorDX, Inc.)
• Revised Emergency Use Authorizations
  • MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
• Reissued Emergency Use Authorizations
  • Nano-Check COVID-19 Antigen Test (Nano-Ditech Corp.)
• CDRH Management Directory by Organization (Updated)

December 20, 2022

• Class I Recall: Arrow International, LLC, subsidiary of Teleflex, Inc Recalls Arrow AutoCAT 2, AC3 Intra-Aortic Balloon Pumps for Unexpectedly Short Battery Run Times
• Transcript and Summary Minutes: November 10, 2022 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
• Transcript and Summary Minutes: November 1, 2022 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220012 added)
• Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices

December 19, 2022

• Revoked Emergency Use Authorizations
  • DETECTR BOOST SARS-CoV-2 Reagent Kit (Mammoth Biosciences, Inc.)
  • SARS-CoV-2 DETECTR Reagent Kit (Mammoth Biosciences, Inc.)
  • COVID-19 ELISA pan-Ig Antibody Test (University of Arizona Genetics Core for Clinical Services)
• Personal Protective Equipment EUAs: Surgical Masks Removed from Appendix A (Updated)
• Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkeypox (mpox) and COVID-19 - January 11, 2023

December 16, 2022

• 2023 OSEL Summer Research Program
• Ventilators and Ventilator Accessories EUAs (Updated)
• Class I Recall: Teleflex and Arrow International, LLC Recall Arrow MAC Two-Lumen Central Venous Access and Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits
• Personal Protective Equipment EUAs: Surgical Masks Removed from Appendix A (Updated)

December 15, 2022

• New Emergency Use Authorizations
  • TaqPath Monkeypox/Orthopox Virus DNA Kit (Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.))
  • Flowflex COVID-19 Antigen Rapid Test (ACON Laboratories, Inc.)
• Updated Emergency Use Authorizations
  • ASSURE-100 Rapid COVID-19 Test (Oceanit Foundry LLC) 
  • Lucira CHECK-IT COVID-19 Test Kit (Lucira Health, Inc.)
• Reissued Emergency Use Authorizations
  • cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (Roche Molecular Systems, Inc.)
  • Pilot COVID-19 At-Home Test (SD Biosensor, Inc.)
• Revised Emergency Use Authorizations
  • Allplex 2019-nCoV Assay (Seegene, Inc.)
  • SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
  • SalivaDirect for use with DTC Kits (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
• CDRH Learn
  • Postmarket Activities - Risk Basics for Medical Devices (New Module) 
  • Postmarket Activities - Application of Risk Management Principles for Medical Devices (New Module) 
  • How to Study and Market Your Device - Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act, Final Guidances (Updated Module)

December 14, 2022

• Revised Emergency Use Authorization
  • Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR (Quest Diagnostics Nichols Institute)
• Digital Health Policy Navigator (Updated)
  • Step 6: Is the Software Function Intended to Provide Clinical Decision Support? (Updated)
• Monkeypox and Medical Devices: Lists of Laboratories Offering Notified Laboratory-Developed Monkeypox Tests (Updated)
• Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results

December 13, 2022

• CDRH Learn (Updated)
  • Specialty Technical Topics - Targeted Box and Blocks Test (tBBT)
• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests: Clip COVID Rapid Antigen Test (Luminostics, Inc.)
• ASCA-Accredited Testing Laboratories (Updated)

December 12, 2022

• Revised Emergency Use Authorization
  • 1copy COVID-19 qPCR Multi Kit (1drop Inc.)
• Transcript and Presentation: COVID-19 and and Monkeypox Test Development and Validation Virtual Town Hall Series - November 30, 2022
• Medical Gloves for COVID-19 (Updated)
• Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
• Supplies of Medical Devices for COVID-19: Frequently Asked Questions (Updated)
• Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quality System Regulation

December 9, 2022

• Class I Recall: Remel, Inc Recalls Thermo Scientific Gram Negative IVD AST Sensititre Plate for risk of potential false susceptible results
• CDRH Learn (Updated)
  • November 2022 Industry Basics Workshop: Understanding Risk with Medical Devices

December 8, 2022

• Chocolate Touch Paclitaxel Coated PTA Ballon Catheter - P210039 (TriReme Medical, LLC)
• Content of Human Factors Information in Medical Device Marketing Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
• Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers - Draft Guidance for Industry and Food and Drug Administration Staff
• Class I Recall: Dewei Medical Equipment Co. Recalls DNA/RNA Preservation Kits That Are Not Authorized, Cleared, or Approved by the FDA
• Federal Register: Content of Human Factors Information in Medical Device Marketing Submissions
• Federal Register: Voluntary Malfunction Summary Reporting Program for Manufacturers

December 7, 2022

• New Emergency Use Authorization
  • Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit (Diazyme Laboratories, Inc.)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkey pox (mpox) and COVID-19 - 12/14/2022
• Augmented Reality and Virtual Reality in Medical Devices
• Non-Invasive Body Contouring Technologies

December 6, 2022

• Revised Emergency Use Authorization
  • ASSURE-100 Rapid COVID-19 Test (Oceanit Foundry LLC)
• Revoked Emergency Use Authorizations
  • Visby Medical COVID-19 Point of Care Test (Visby Medical, Inc.)
  • Visby Medical COVID-19 (Visby Medical, Inc.)
• Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication
• VENTANA FOLR1 (FOLR-2.1) RxDx Assay - P220006 (Ventana Medical Systems, Inc.)

December 5, 2022

• UPDATE: Impella RP System Post-Approval Study Results and Updated Labeling - Letter to Health Care Providers
• Printable Slides: Webinar – Final Guidances on Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act

December 2, 2022

• Updated Emergency Use Authorizations
  • SalivaDirect DTC Saliva Collection Kit (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
  • SalivaDirect At-Home Collection Kit (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
• Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) Shortage - Letter to Health Care Providers
• Getinge’s Maquet/Datascope IABP Devices: Update on Device Failure – Letter to Health Care Providers (Updated)
• Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
• MedSun Newsletter, December 2022
• Medical Device Accessory Classification Request Granting Decisions (Updated)
• List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)

December 1, 2022

• Revoked Emergency Use Authorization
  • MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay (University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory)
• Webinar - Final Guidances on Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act - December 6, 2022
• Recalls Related to the HVAD System (Updated)

November 30, 2022

• Federal Register: Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee

November 29, 2022

• EUA Template for Developers of Antigen Diagnostic Tests
• EUA Summary Template for Developers of Antigen Diagnostic Tests for Monkeypox
• Avive Automated External Defibrillator (AED) and Accessories - P210015 (Avive Solutions, Inc.)
• ASCA-Accredited Testing Laboratories (Updated)
• CDRH Petitions (Updated)
• Extended Expiration Date for Flowflex COVID-19 Antigen Home Test
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190022, DEN200015, DEN200016, DEN200055, and DEN200066 added)

November 28, 2022

• The Spanner Temporary Prostatic Stent - P060010/S013 (SRS Medical Systems, Inc.)
• Delisted Emergency Use Authorization
  • SARS-Cov-2 Assay (Diagnostic Molecular Laboratory - Northwestern Medicine)
• Medical Device Development Tools (MDDT): CHemical RISk Calculator (CHRIS) - Color Additives

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