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        Medical Devices News and Events

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          Medical Devices News and Events
          CDRHNew - News and UpdatesMedical Devices News and Events CDRHNew - News and Updates
  			A comprehensive list of the latest CDRH updates.
	
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This Week in CDRH

January 30, 2024

Class I Recall:  Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration ErrorJanuary 29, 2024

Updated Emergency Use Authorization
	UOL COVID-19 Test (Uh-Oh Labs Inc.)
	CDRH Statement on Philips’ AnnouncementJanuary
	January 26, 2024

ASCA-Accredited Testing Laboratories (Updated)
	Consumer Information - OncomineTM Dx Target Test- P160045/S025 (Life Technologies Corporation)January 25, 2024

Revised Emergency Use Authorization
	Rapid SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)January 24, 2024

FDA Elevates Office of Strategic Partnerships and Technology Innovation to Super Office in CDRH
	Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication (Updated)
	Windstone Medical Packaging dba Aligned Medical Solutions
	Federal Register: Emergency Use Authorization: Certain Medical Devices during COVID-19January 23, 2024

CLIA Waiver by Application Decision Summaries (Updated)
	Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO)January 22, 2024

Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices - Draft Guidance for Industry and Food and Drug Administration Staff
	ASCA-Accredited Testing Laboratories (Updated)
	CDRH Learn (Updated)
	Presentation and Transcript for Webinar - Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance - January 11, 2024
	Federal Register: Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic DevicesJanuary 19, 2024

Meeting Notice: February 13, 2024 Circulatory System Devices Panel of the Medical Devices Advisory Committee
	Ventilators and Ventilator Accessories EUAs (Updated)
	Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory CommitteeJanuary 18, 2024

FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made
	CDRH Learn (Updated)
	Presentation and Transcript for Medical Device Sterilization Town Hall: Overview of Sterilization Landscape and Role of Ethylene Oxide - January 10, 2024
	Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
	Historical Information about Device Emergency Use Authorizations (Updated)January 17, 2024

CDRH 2023 Annual Report
	Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication (Updated)
	CDRH Petitions (Updated)
	CLIA Waiver by Application Decision Summaries (Updated)January 16, 2024

Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns (Updated)
	Class I Recall: ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility
	Risks with Exactech Equinoxe Shoulder System with Defective Packaging - FDA Safety CommunicationJanuary 12, 2024

Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA)
	Class I Recall: Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference
	Report to Congress: Device Pilot Projects FY 2022January 11, 2024

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
	Class I Recall: Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
	Class I Recall: ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical DevicesJanuary 10, 2024

V-CHAMPS Challenge WinnersJanuary 9, 2024

Potential Exposure to Certain Chemicals with Use of GE HealthCare EVair and EVair03 Compressors with Certain Ventilators – Letter to Health Care Providers
	Transcript and Summary Minutes: November 29, 2023 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting
	Transcript and Summary Minutes: AMENDED INFORMATION: October 20, 2022 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
	At-Home OTC COVID-19 Diagnostic Tests (Updated)
	InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.) - Extended Expiration DateJanuary 8, 2024

Revised Emergency Use Authorization
	Advin COVID-19 Antigen Test @Home (Advin Biotech Inc.)
	Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff (Updated)
	Sterilization for Medical Devices (Updated)
	Transcript: September 6, 2023 Patient Engagement Advisory Committee Meeting
	Class I Recall: Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error
	Class I Recall: Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns
	Medical Device Sterilization Town Hall: Overview of Sterilization Landscape and Role of Ethylene Oxide - January 10, 2024January 5, 2024

Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication (Updated)January 4, 2024

ASCA-Accredited Testing Laboratories (Updated)January 3, 2024

Updated Emergency Use Authorizations
	Rapid SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
		Lucira by Pfizer COVID-19 & Flu Home Test (Pfizer Inc.)
	Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers (Updated)
	Do Not Use Synovo Total Hip Resurfacing System: FDA Safety CommunicationJanuary 2, 2024

Transition to Electronic Export Documents - Letter to Industry
	MedSun Newsletter - January 2024
	MQSA National Statistics (Updated)

December
	December 27, 2023

HSV-2 Tests for Genital Herpes Can Produce False Reactive Results - Letter to Clinical Laboratory Staff and Health Care ProvidersDecember 22, 2023

Consumer Information: RHA 3 dermal filler - P170002/S030 (Teoxane SA)December 21, 2023

Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force (Updated)
	Network of Experts Program: Connecting the FDA with External Expertise (Updated)
	2024 OSEL Summer Research Program (Updated)
	COVID-19 Tests Granted Traditional Marketing Authorization by the FDA (Updated)
	Xpert® Xpress CoV-2 plus (Cephid)December 20, 2023

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations
	Federal Register: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability
	Class I Recall: Philips North America LLC Recalls Panorama 1.0T HFO due to a Risk of Explosion During a Quench Procedure Caused by Excessive Pressure Buildup of Helium Gas
	At-Home OTC COVID-19 Diagnostic Tests (Updated)
	Pilot COVID-19 At-Home Test (SD Biosensor, Inc.) - Extended Expiration DatesDecember 19, 2023

CDRH Statement: FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder
	Class I Recalls: 
	Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject Syringes (Updated)
		Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire
		Medtronic Navigation Inc. Recalls StealthStation S8 Application Version 2.0 and 2.0.1 Due to a Software Glitch
	Summary Minutes: November 7, 2023 Radiological Devices Panel of the Medical Devices Advisory Committee MeetingDecember 18, 2023

Federal Register: Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff; Availability
	Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
	CDRH Learn (Updated)
	Presentation and Transcript for Webinar - Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling - December 5, 2023
	Send and Track Medical Device Premarket Submissions Online: CDRH Portal (Updated)
	Total Product Life Cycle Advisory Program (TAP) (Updated)
	Recognized Consensus Standards Database (Updated)December 15, 2023

Breast Implants (Updated)
	Risks and Complications of Breast Implants (Updated)
	Labeling for Approved Breast Implants (Updated)
	Medical Device Reports for Systemic Symptoms in Women with Breast Implants (Updated)
	Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (Updated)
	Breast Implant Postmarket Safety Information (Updated)December 14, 2023

New Emergency Use Authorizations
	Gx HTIQ SARS-CoV-2 Test (RCA Laboratory Services LLC dba GENETWORx)
		Gx HTKB SARS-CoV-2 Test (RCA Laboratory Services LLC dba GENETWORx)
	Revised Emergency Use Authorization
	Clear Dx SARS-CoV-2 WGS v3.0 Test (Laboratory Corporation of America (Labcorp))
		Pilot COVID-19 At-Home Test (SD Biosensor, Inc.)
	How to Prepare a Traditional 510(k) (Updated)December 12, 2023

Webinar - Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program - 12/12/23 (Printable Slides added)
	CDRH Learn - Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program (New Module 12/11/23)December 8, 2023

Class I Recall: Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive
	MedSun Newsletter - December 2023December 7, 2023

CDRH Partnerships to Advance Innovation and Regulatory Science (PAIRS) Program (Updated)December 6, 2023

eSTAR Program (Updated)December 5, 2023

Class I Recall: Cordis US Corp Recalls INFINITI Angiographic Catheter due to Products Being Shipped Without Undergoing Sterilization ProceduresDecember 4, 2023

Transcript for November 7, 2023 Radiological Devices Panel of the Medical Devices Advisory Committee Meeting
	24 Hour Summary and Presentations for November 29, 2023 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting
	Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication (Updated)
	Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Device TrackingDecember 1, 2023

Class I Recall: Eitan Medical Ltd Recalls Sapphire Infusion Pumps for Failure to Detect Air in the Line
	MQSA National Statistics (Updated)
	Total Product Life Cycle Advisory Program (TAP) (Updated)
	Class I Recall: Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject Syringes

November
	November 30, 2023

FDA Safety Communication: Evaluating Plastic Syringes Made in China for Potential Device FailuresNovember 29, 2023

Antimicrobial Resistance Information from FDA (Updated)
	Federal Register: Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials
	Federal Register: Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes
	Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men – Letter to Health Care Providers (Updated)
	ASCA-Accredited Testing Laboratories (Updated)November 28, 2023

Updated Emergency Use Authorization
	BinaxNOW COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
	Medical Device Single Audit Program (MDSAP) (Updated)
	Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety CommunicationNovember 27, 2023

The FDA Withdraws as a Member of the Global Harmonization Working Party
	Class I Recall: Unomedical A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector Piece Causing Unexpected Disconnections
	Webinar - Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program - 12/12/2023
	Materials for November 29, 2023 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting
	Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Shortages Data CollectionsNovember 21, 2023

Current Career Opportunities at CDRH (Updated)
	ASCA-Accredited Testing Laboratories (Updated)November 20, 2023

Letter to Health Care Providers: Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps
	At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
	CDRH Learn (Updated)
	Presentation and Transcript for Webinar: Breakthrough Devices Program Updated Final Guidance, November 14, 2023
	Scientific Research Jobs, Fellowships, and Collaborations on Medical Devices (Updated)
	2024 OSEL Summer Research Program
	FDA Safety Communication: Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and AccessoriesNovember 17, 2023

Meeting Notice: February 2, 2024: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
	Meeting Notice: February 6, 2024 General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee
	Class I Recall: B. Braun Medical, Inc. Recalls Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, Non-Wireless BATTERY PACK Due to Faulty Occlusion Alarm
	MedSun Newsletter - November 2023November 16, 2023

New Emergency Use Authorization
	cobas SARS-CoV-2 & Influenza A/B v2 (Roche Molecular Systems)
	Updated Emergency Use Authorization
	OSOM COVID‐19 Antigen Rapid Test - Letter Granting EUA Revision(s) (November 15, 2023)
	MDUFA Reports (Updated) 
	November 16, 2023 MDUFA V Performance Report
		November 16, 2023 MDUFA IV Performance Report
	Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act - Guidance for Industry and Food and Drug Administration Staff
	Select Updates for the 506J Guidance: 506J Device List and Additional Notifications - Draft Guidance for Industry and Food and Drug Administration Staff
	Supply and Shortages of Medical Devices: Frequently Asked Questions (Updated)
	Medical Device Supply Chain and Shortages (Updated)
	506J Device List
	Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff
	Credibility of Computational Models Program: Research on Computational Models and Simulation Associated with Medical Devices (Updated)
	Webinar - Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance - January 11, 2024
	CDRH Petitions (Updated)
	Artificial Intelligence Program: Research on AI/ML-Based Medical Devices (Updated)
	CDRH Statement: CDRH Takes Steps to Advance Further Discussions on Pulse Oximeters
	Pulse Oximeters
	Pulse Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
	Class I Recall: Asensus Surgical Inc. Recalls Senhance Surgical System Due to Malfunctions with Unintended Movement of the Robotically-Assisted Surgical Device
	Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee, Pulse Oximeters
	Federal Register: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee
	Federal Register: Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device under the Federal Food, Drug, and Cosmetic Act and Select Updates
	Federal Register: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
	Federal Register: Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee
	Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220087, DEN220090, DEN220091 and DEN230002 added)November 15, 2023

Collaborative Communities: Addressing Health Care Challenges Together (Updated)
	CDRH Petitions (Updated)
	24 Hour Summary and Presentations for November 7, 2023 Radiological Devices Panel of the Medical Devices Advisory Committee Meeting
	Cybersecurity (Updated)
	Class I Recall: Baxter Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential Underdosing
	Class I Recall: Fresenius Medical Care Recalls Sanxin Single Use Syringes for LeakagesNovember 14, 2023

Meeting Notice: November 29, 2023 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee
	Total Product Life Cycle Advisory Program (TAP) (Updated)
	Class I Recall: Cardinal Health Recalls Monoject Disposable Syringes for Incompatibilities with Syringe PumpsNovember 13, 2023

Class I Recall: Covidien LLC Recalls McGRATH MAC Video Laryngoscope Due to Stolen Defective ProductsNovember 10, 2023

Federal Register: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, Multi-Cancer Detection DevicesNovember 9, 2023

Labeling Updates for BD Mesh Products - Letter to Health Care ProvidersNovember 8, 2023

Withdrawn or Expired Guidance (Updated)
	Coronavirus (COVID-19) and Medical Devices (Updated)
	Emergency Use Authorizations for Medical Devices (Updated)
	FAQs on Testing for SARS-CoV-2 (Updated)
	Importing Medical Devices Relating to COVID-19 (Updated)
	Ventilators and Ventilator Accessories EUAs (Updated)
	Ventilators and Ventilator Accessories for COVID-19 (Updated)
	FAQs on Viral Transport Media During COVID-19 (Updated)
	Registration and Listing of Medical Devices Relating to COVID-19 (Updated)
	Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19 (Updated)
	Contacts for Medical Devices Related to COVID-19 (Updated)
	Federal Register: Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen ConditionsNovember 7, 2023

Summary Minutes for August 22-23, 2023: Circulatory System Devices Panel of the Medical Devices Advisory Committee MeetingNovember 6, 2023

Recognized Consensus Standards: Medical Devices
	Class I Recall: Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling
	Do Not Use Certain Brands of Saline and Sterile Water Medical Products by Nurse Assist Because They May Not Be Sterile: FDA Safety CommunicationNovember 3, 2023

Consumer Information: Boston Scientific Cardiac Cryoablation System - P220032 (Boston Scientific Corporation)
	Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices - Guidance for Industry and Food and Drug Administration Staff
	CDRH Learn (Updated)
	Transcript for Webinar: CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program - October 26, 2023
	Meeting materials for November 7, 2023 Radiological Devices Panel of the Medical Devices Advisory Committee
	Transcript and Summary Minutes for September 7-8, 2023 Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting
	Medical Device Single Audit Program (MDSAP) (Updated)
	Federal Commission for Protection from Sanitary Risks (COFEPRIS) of Mexico (NEW)November 2, 2023

Enforcement Policy for Clinical Electronic Thermometers - Guidance for Industry and Food and Drug Administration Staff
	Non-contact Infrared Thermometers (Updated)
	MQSA National Statistics (Updated)
	Consumer Information: LimFlowTM System - P220025 (LimFlow, Inc.)
	Federal Register: Enforcement Policy for Clinical Electronic Thermometers
	Federal Register: Exemptions from Premarket Notification: Class II Devices; Clinical Electronic Thermometers
	CDRH seeks public comment: Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 DiabetesNovember 1, 2023

At-Home OTC COVID-19 Diagnostic Tests (Updated)

	MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.) - Extended Expiration Dates
	Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions - Guidance for Industry and Food and Drug Administration Staff
	Webinar - Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling - December 5, 2023 (Date Changed)
	Federal Register: Enforcement Policy for Certain Supplements for Approved Premarket Approval or Humanitarian Device Exemption Submissions
	Federal Register: Charter Amendments, Establishments, Renewals and Terminations: Patient Engagement Advisory Committee

October
	October 31, 2023

Updated Emergency Use Authorizations
	STANDARD Q COVID-19 Ag Test 2.0 (SD Biosensor, Inc.)
		TangenDx SARS-CoV-2 Molecular Test (Tangen Biosciences, Inc.)
	CDRH Petitions (updated)
	Explore Life at CDRH
	Federal Register: Requests for Nominations: Public Advisory Panels of the Medical Devices Advisory CommitteeOctober 30, 2023

FDA Activities Related to Essure (Updated)
	Information for Patients and Health Care Providers: Essure (Updated)
	Laboratory Developed Tests (Updated)
	Class I Recall: Olympus Recalls Olympus High Flow Insufflation Unit Due to Over-InflationOctober 27, 2023

Revised Emergency Use Authorization
	MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)October 24, 2023

Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
	CDRH Issues Guiding Principles for Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices
	CDRH Learn (Updated)
	Presentation and Transcript for Webinar: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” - Final Guidance
	Class I Recall: Fresenius Medical Care Recalls Some Hemodialysis Machines for Potential Exposure to Toxic CompoundsOctober 23, 2023

CDRH Trade Press Contact Information
	About Manufacturer and User Facility Device Experience (MAUDE) (Updated)October 20, 2023

Class I Recall: Philips Respironics Recalls V60 and V60 Plus Ventilators due to Power Management Printed Circuit Board Assemblies (PM PCBAs) Not Meeting Ventilator Standards
	Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210011, DEN210056, DEN220023, DEN220026, DEN220052, DEN220073, 
	DEN230006, DEN230007, DEN230019, and DEN230021 added)October 19, 2023

Medical Device Shortages List (Updated)
	Consumer Information: PALMAZ MULLINS XD Pulmonary Stent - P220004 (Cordis US Corp.)
	Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (Updated)October 18, 2023

Class I Recall: Hamilton Medical Inc. Recalls HAMILTON-C1, T1, MR-1 Ventilators for Capacitator Leaks and Short Circuits
	Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring - Guidance for Industry and Food and Drug Administration Staff
	Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety Communication (Updated)
	Total Product Life Cycle Advisory Program (TAP) (Updated)October 17, 2023

FDA Announces Collaboration with NIH for a Funding Opportunity Supporting the Small Business Community in Developing Medical Device Development ToolsOctober 16, 2023

New Emergency Use Authorization
	MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR (MAWD Laboratories)
	Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers (Updated)
	Webinar - Proposed Rule: Medical Devices; Laboratory Developed Tests - 10/31/2023October 13, 2023

Consumer Information: CRCdx(R) RAS Mutation Detection Kit- P220005 (EntroGen, Inc.)October 12, 2023

Updated Emergency Use Authorization
	Rize Laboratory SARS nCoV-2019 Multiplexed Assay (Rize Laboratory)
	Public Webinar – Breakthrough Devices Program Updated Final Guidance – November 14, 2023
	Center for Devices and Radiological Health (CDRH) Compliance Programs (Updated)October 11, 2023

Digital Health Advisory Committee
	MedSun Newsletter - October 2023
	Federal Register: Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
	Federal Register: Requests for Nominations: Individuals and Consumer Organizations for the Digital Health Advisory Committee
	Federal Register: Requests for Nominations: Individuals and Industry Organizations for the Digital Health Advisory Committee
	Federal Register: Requests for Nominations: Voting Members for the Digital Health Advisory CommitteeOctober 10, 2023

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff
	Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
	CDRH Proposed Guidances for Fiscal Year 2024 (FY2024)
	CDRH Proposed Guidance DevelopmentOctober 6, 2023

Revoked Emergency Use Authorization
	SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay (Drexel University College of Medicine)
	List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
	Federal Register: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of MpoxOctober 5, 2023

CDRH Provides Update on Philips June 2021 Recall and Maintains Recommendations Related to Potential Health Risks of PE-PUR Foam
	Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
	Third Party Performance Report - FY23, Q4October 4, 2023

Virtual Public Workshop – Extended Reality in Orthopedic Surgical Devices: Insights into User Experience and Adverse Event Reporting for Patient Safety - November 2, 2023
	Medical Devices Cybersecurity: Infographic
	MQSA National Statistics (Updated)
	CDRH Statement: CDRH Recognizes 10-Year Anniversary of Cybersecurity Program and Continued Steps to Help Ensure Medical Device Cybersecurity
	Federal Register: Emergency Use Authorization: In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19
	Federal Register: Meetings: Radiological Devices Panel of the Medical Devices Advisory CommitteeOctober 3, 2023

At-Home OTC COVID-19 Diagnostic Tests - Shelf Life Extended
	Advin COVID-19 Antigen Test @Home (Advin Biotech, Inc.)
		OHC COVID-19 Antigen Self Test (OSANG LLC)
		InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.)
	Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
	Federal Register: Revocation of Authorization of Emergency Use: Becton, Dickinson and Company Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site)October 2, 2023

Revised Emergency Use Authorizations
	3EO Health COVID-19 Test (3EO Health, Inc.)
	Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff
	eSTAR Program (Updated)
	CDRH Statement: CDRH Provides Update on the Total Product Life Cycle Advisory Program Pilot
	Total Product Life Cycle Advisory Program (TAP) (Updated)

                                                                                  Content current as of:
      01/30/2024
                  
                   
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