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

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510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations

Federal Register: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability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 Dates

December 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 Meeting

December 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Federal Register: Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff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)

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)

Class I Recall: Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive

MedSun Newsletter - December 2023

December 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 Procedures

December 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 Tracking

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

FDA Safety Communication: Evaluating Plastic Syringes Made in China for Potential Device Failures

November 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 Communication

November 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 Collections

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 Accessories

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 2023

November 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 Leakages

November 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 Pumps

November 13, 2023

Class I Recall: Covidien LLC Recalls McGRATH MAC Video Laryngoscope Due to Stolen Defective Products

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

Labeling Updates for BD Mesh Products - Letter to Health Care Providers

November 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 Conditions

November 7, 2023

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

November 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 Communication

November 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 Diabetes

November 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

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 Committee

October 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-Inflation

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 Compounds

October 23, 2023

CDRH Trade Press Contact Information

About Manufacturer and User Facility Device Experience (MAUDE) (Updated)

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 Tools

October 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 - 10/31/2023

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 Committee

October 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 Development

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 Mpox

October 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, Q4

October 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 Committee

October 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)

New Emergency Use Authorizations
- STANDARD Q COVID-19 Ag Test 2.0 (SD Biosensor, Inc.)
- TangenDx SARS-CoV-2 Molecular Test (Tangen Biosciences, Inc.)

Revised Emergency Use Authorizations
- InteliSwab COVID-19 Rapid Test Rx (OraSure Technologies, Inc.)
- InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.)
- InteliSwab COVID-19 Rapid Test Pro (OraSure Technologies, Inc.)
- MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
- OHC COVID-19 Antigen Self Test (OSANG LLC)

Revoked Emergency Use Authorization
- Kaiser Permanente High Throughput SARS-CoV-2 Assay (Southern California Permanente Medical Group)

Laboratory Developed Tests (Updated)

Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication

At-Home OTC COVID-19 Diagnostic Tests (Updated)
- At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)

COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2 (Updated)

Federal Register: Medical Devices: Laboratory Developed Tests

September 28, 2023

Updated Emergency Use Authorizations
- Zika MAC-ELISA (CDC)

Revised Emergency Use Authorizations
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators (Ortho-Clinical Diagnostics, Inc.)

Electronic Submission Template for Medical Device De Novo Requests - Draft Guidance for Industry and Food and Drug Administration Staff

SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests

Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling - Guidance for Industry and Food and Drug Administration Staff

Webinar – Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices – Updating Breakpoints in Device Labeling

COVID-19 Tests Granted Traditional Marketing Authorization by the FDA

Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology - Guidance for Industry and Food and Drug Administration Staff

Federal Register: Antimicrobial Susceptibility Test System Devices--Updating Breakpoints in Device Labeling

Federal Register: Electronic Submission Template for Medical Device De Novo Requests

Federal Register: Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology

September 27, 2023

Personal Protective Equipment EUAs (Updated)

September, 26, 2023

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff

Cybersecurity (Updated)

Cybersecurity in Medical Devices Frequently Asked Questions (FAQs) (Updated)

Webinar - Final Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - November 2, 2023

Federal Register: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

New Emergency Use Authorization
- 3EO Health COVID-19 Test (3EO Health, Inc.)

Consumer Information on: AAV5 DetectCDx – P190033 (ARUP Laboratories)

CDRH Recruitment Calendar

September 21, 2023

Revised Emergency Use Authorizations
- Advin COVID-19 Antigen Test @Home (Advin Biotech, Inc.)
- Bio-Self COVID-19 Antigen Home Test (BioTeke USA, LLC.)
- C-Sync COVID-19 Antigen Test (Biosynchronicity Corporation)
- Cue Mpox (Monkeypox) Molecular Test (Cue Health, Inc.)

At-Home OTC COVID-19 Diagnostic Tests (Updated Lucira by Pfizer COVID-19 & Flu Home Test)

September 20, 2023

Class I Recall: Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile

Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)

September 19, 2023

CDRH Statement: CDRH Announces International Harmonization Strategic Plan

CDRH International Affairs (Updated)

CDRH Learn (Updated)
- Presentation and Transcript for Webinar: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Draft Guidance
- Presentation and Transcript for Webinar: Qualification of Medical Device Development Tools: Final Guidance

Standards and Conformity Assessment Program (Updated)

Accreditation Scheme for Conformity Assessment (ASCA) (Updated)

Accreditation Bodies: How to Participate in ASCA (Updated)

Manufacturers: How to Participate in ASCA (Updated)

ASCA-Accredited Testing Laboratories (Updated)

ASCA-Recognized Accreditation Bodies (Updated)

Testing Laboratories: How to Participate in ASCA (Updated)

How to Study and Market Your Device (Updated)

Digital Health Frequently Asked Questions (FAQs)

Virtual Public Workshop – Patient-Reported Outcomes and Vision Related Quality of Life Questionnaires, September 29, 2023 - 09/29/2023

September 14, 2023

Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations - Draft Guidance for Industry and Food and Drug Administration Staff

Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff

Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program - Guidance for Industry and Food and Drug Administration Staff

Weight-Loss and Weight-Management Devices (Updated)

Breakthrough Devices Program - Guidance for Industry and Food and Drug Administration Staff

Breakthrough Devices Program (Updated)

CDRH Statement: CDRH Issues Updated Final Guidance on Breakthrough Devices Program

Webinar - Breakthrough Devices Program Updated Final Guidance - November 14, 2023

Federal Register: Medical Devices with Indications Associated with Weight Loss Guidances

Federal Register: Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary Improvement Program

Federal Register: Breakthrough Devices Program

September 13, 2023

MDUFA Reports (Updated)
- September 11, 2023 MDUFA V Performance Report
- September 11, 2023 MDUFA IV Performance Report

Class I Recall: Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode

September 12, 2023

Class I Recall: Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly

New Emergency Use Authorization
- ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test (Princeton BioMeditech Corp.)

Updated Emergency Use Authorizations
- Lucira by Pfizer COVID-19 & Flu Home Test (Pfizer Inc.)
- Lucira by Pfizer COVID-19 & Flu Test (Pfizer Inc.)

Voluntary eSTAR Program (Templates updated)

Postmarket Device Safety-Related Communications Report to Congress

Total Product Life Cycle Advisory Program (TAP) (Updated)

Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication (Updated)

MedSun Newsletter - September 2023

September 7, 2023

Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff

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 - October 12, 2023

Basics of Biocompatibility: Information Needed for Assessment by the FDA (Updated)

Glossary of Biocompatibility Terms (Updated)

What Should I Put in a Test Report? (Updated)

Biocompatibility Evaluation Endpoints by Device Category (Updated)

Biocompatibility Evaluation Endpoints by Contact Duration Periods (Updated)

Component and Device Documentation Examples for Test Articles or Previously Marketed Devices (Updated)

Consumer Information: CraniSeal Dural Sealant - P220014 (Pramand, LLC)

August 2023 PMA Approval Listing (Updated)

September 6, 2023

Evidentiary Expectations for 510(k) Implant Devices - Draft Guidance for Industry and Food and Drug Administration Staff

Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff

Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission - Draft Guidance for Industry and Food and Drug Administration Staff

Webinar - CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program - October 26, 2023

CDRH Statement: FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program

FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program - Program Updates

510(k) Program Evaluations and Reports

Total Product Life Cycle for Medical Devices

510(k) Clearances

Medical Device Safety and the 510(k) Clearance Process

STEM Career Opportunities at CDRH (Updated)

Federal Register: Modernizing the Premarket Notification Program

September 5, 2023

Enforcement Policy for Face Masks and Barrier Face Coverings for Coronavirus Disease (COVID-19) Response - Guidance for Industry and Food and Drug Administration Staff

Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19 (Updated)

STEM Career Opportunities at CDRH (Added Executive Officer / Office Director (OM) - CURES)

FDA Offers Tips about Medical Devices and Natural Disasters (Updated)

Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Health Care Providers, Device Manufacturers, and Distributors (Updated)

eMDR System Enhancements (Updated)

Coding Resources for Medical Device Reports (Updated)

Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files (Updated)

Consumer Information on: HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads – P200007

Augmented Reality and Virtual Reality Medical Devices: Questions to Consider

Materials posted for September 6, 2023 Patient Engagement Advisory Committee Meeting

Webinar - Qualification of Medical Device Development Tools - September 12, 2023

Total Product Life Cycle Advisory Program (TAP) (Updated)

MQSA National Statistics (Updated)

510(k) Third Party Performance Metrics and Accreditation Status (Updated)

Consumer Information: Minitouch 3.8 Era System - P230002 (MicroCube, LLC)

Consumer Information: SurVeil Drug-Coated Ballon - P210025 (Surmodics, Inc.)

Reissued Emergency Use Authorization
- Aptima SARS-CoV-2 Assay (Hologic, Inc.)

Updated Emergency Use Authorization
- Aptima Zika Virus Assay (Hologic, Inc.)

Revised Emergency Use Authorization
- iHealth COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) – Letter to Health Care Providers

Class I Recalls:
- Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature Alarms Causing Pump Stops
- Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Autofill Failure Alarms Resulting in Pump Stops
- Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Gas Loss and Gas Gain Failures
- Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Power Failures When Device is Unseated from Cart

August 30, 2023

Class I Recall: Hamilton Medical Inc. Recalls HAMILTON-C1, C2, C3, T1 Ventilators for Software Issues that May Cause Ventilators to Stop Without Notice

August 29, 2023

STEM Career Opportunities at CDRH (Updated)

Reminder: Patient Engagement Advisory Committee (PEAC) Virtual Meeting on Advancing Health Equity in Medical Devices

Medical Device Development Tools (MDDT) (Added Accelerated Testing to Prove Long-Term Material Biostability - Summary of Evidence and Basis of Qualification (SEBQ))

Medtronic HeartWare Ventricular Assist Device (HVAD) System (Updated)

Recommendations for Patients and Health Care Providers: HVAD System (Updated)

Recalls Related to the HVAD System (Updated)

August 24, 2023

Updated Emergency Use Authorizations
- InteliSwab COVID-19 Rapid Test Pro (OraSure Technologies, Inc.)
- LumiraDx SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)

Revoked Emergency Use Authorizations
- SARS-CoV-2 (N gene detection) Test (Exact Sciences Laboratories)
- COVID-Flu Multiplex Assay (Exact Sciences Laboratories)
- Hymon SARS-CoV-2 Test Kit (dba SpectronRX)

August 23, 2023

Class I Recall: Draeger Recalls Carina Sub-Acute Care Ventilators for Contaminants in Airpath

August 22, 2023

Medical Device User Fee Amendments 2022 (MDUFA V) (Added "An Introduction to the Medical Device User Fee Program: MDUFA V")

Mammography Facility Adverse Event and Action Report – August 22, 2023: Phelps Memorial Health Center

August 21, 2023

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200052, DEN220047, DEN220048, DEN220058, DEN230003 and DEN230012 added)

Meeting materials posted for August 22-23, 2023 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting

August 17, 2023

Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication (Updated)

Class I Recall: Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA Failures Affecting the Ability to Charge the Batteries Leading to Unexpected Shutdowns

Class I Recall: Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots

August 16, 2023

Tips for Submitting Comments on CDRH Guidance Documents

August 15, 2023

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200043, DEN220006 and DEN220028 added)

August 14, 2023

Global Unique Device Identification Database (GUDID) (Updated)

Meeting Notice: September 7-8, 2023 Microbiology Devices Panel of the Medical Devices Advisory Committee

FY 2019-FY 2020 Pediatric Report to Congress

At-Home OTC COVID-19 Diagnostic Tests (Updated Lucira by Pfizer COVID-19 & Flu Home Test - Shelf Life Extension)

Class I Recall: Philips Respironics Recalls Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators After Finding Dust and Dirt in Air Path That Can Reduce Air Flow to Patients

Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff

ASCA-Accredited Testing Laboratories (Updated)

Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety Communication

August 10, 2023

Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)

CDRH Petitions (Updated)

Class I Recall: Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns

Federal Register: Medical Devices; Reports of Corrections and Removals

August 9, 2023

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

Device Registration and Listing (Updated)

Medical Device User Fee Amendments (MDUFA) (Updated)

Consumer Information: TOPS System – P220002

August 7, 2023

Federal Register: Medical Devices; Device Tracking

New Emergency Use Authorization
- Clear Dx SARS-CoV-2 WGS v3.0 Test (Laboratory Corporation of America / Labcorp)

Revised Emergency Use Authorizations
- Lucira by Pfizer COVID-19 & Flu Home Test (Pfizer Inc.)
- Lucira by Pfizer COVID-19 & Flu Test (Pfizer Inc.)

August 3, 2023

Updated Emergency Use Authorizations
- BD Respiratory Viral Panel for BD MAX System (Becton, Dickinson and Company (BD)
- cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems)
- Sofia 2 Flu + SARS Antigen FIA (Quidel Corporation)

Revoked Emergency Use Authorization
- SPERA COVID-19 Ag Test (Xtrava Health)

MedSun Newsletter - August 2023

CDRH's Experiential Learning Program (ELP) (Updated)

August 1, 2023

CDRH Learn (Updated)
- Presentation and Transcript for Webinar: Content of Premarket Submissions for Device Software Functions, Final Guidance

Class I Recall: Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with Dose IQ Safety Software for Repeat Upstream Occlusion False Alarms

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

MQSA National Statistics (Updated)

Federal Register: Modifications to the List of Recognized Standards, Recognition List Number: 059

Consumer Information: Perclose ProStyle Suture-Mediated Closure and Repair System and Perclose ProGlide Suture-Mediated Closure Systems - P960043/S118

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)

Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration - Letter to Health Care Providers

Total Product Life Cycle Advisory Program (TAP) (Updated)

GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings

Consumer Information: LiquiFix FIX8 and LiquiFix Precision Hernia Mesh Fixation Devices - P220024 (Advanced Medical Solutions, Limited)

CDRH Petitions (Updated)

July 27, 2023

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Draft Guidance for Industry and Food and Drug Administration Staff

Webinar - Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Draft Guidance - September 14, 2023

Class I Recall: Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent

Federal Register: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder

Federal Register: Medical Devices--Voluntary Improvement Program

Federal Register: Medical Device User Fee Rates for Fiscal Year 2024

Federal Register: Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations--Premarket Notification (510(k)) Submissions

July 26, 2023

Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers (Updated)

Registration and Listing of Medical Devices Relating to COVID-19 (Updated)

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff

Class I Recall: Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism

Hydrogen Peroxide Solution (Updated)

July 25, 2023

Revised Emergency Use Authorization
- C-Sync COVID-19 Antigen Test (Biosynchronicity Corporation)

Consumer Information: DETOUR Systems - P220021 (Endologix, LLC)

Consumer Information: FoundationOne Liquid CDx (F1 Liquid CDx) - P190032/S010 (Foundation Medicine, Inc.)

July 24, 2023

CDRH Announces New Standards Recognition to Support Innovation in Medical Device Sterilization

Sterilization for Medical Devices (Updated)

Consumer Information: PerClot Polysaccharide HemoStatic System - P210036 (Artivion, Inc. (formerly CryoLife, Inc.)

New Emergency Use Authorization
- ALPHADx SARS-COV-2 RT-PCR Test (Alphadera Labs, LLC)

Class I Recall: Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients (Updated)

July 20, 2023

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

New Emergency Use Authorization
- Swab-N-Go Home Test COVID-19 Ag (Immunostics Inc.)

Revised Emergency Use Authorization
- Alinity m MPXV (Abbott Molecular, Inc.)

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

July 19, 2023

Consumer Information: Optilume BPH Catheter System - P220029 (Urotronic, Inc.)

Revised Emergency Use Authorizations
- Metrix COVID-19 Test (Aptitude Medical Systems Inc.)
- Xpert Xpress CoV-2/Flu/RSV plus (Cepheid)

Updated Emergency Use Authorization
- LumiraDx SARS-CoV-2 RNA STAR (LumiraDx UK, LTD)

Use Alternative Testing Method for the Quidel Cardiovascular Inc. Quidel Triage Cardiac Panel - Letter to Health Care Providers

CDRH Learn (Updated)
- Device Registration and Listing: An Introduction – Part 1
- Device Registration and Listing: An Introduction – Part 2
- An Introduction to the Medical Device User Fee Program: MDUFA V

July 18, 2023

Revoked Emergency Use Authorization
- BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) (Becton, Dickinson and Company)

Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy

Consumer Information: Eversense E3 Continuous Glucose Monitoring (CGM) System - P160048/S021 (Senseonics, Incorporated)

CDRH Learn (Updated)
- Printable Slides for Content of Premarket Submissions for Device Software Functions, Final Guidance

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)

At-Home OTC COVID-19 Diagnostic Tests
- Expiration Dates Extended: MaximBio ClearDetect COVID-19 Antigen Home Test

July 17, 2023

Class I Recall: Quidel Cardiovascular Inc. Recalls Quidel Triage Cardiac Panels for Risk of False Negative Troponin Results that Could Cause Delayed Diagnosis or Missed Myocardial Infarction

Qualification of Medical Device Development Tools - Guidance for Industry, Tool Developers, and Food and Drug Administration Staff

Medical Device Development Tools (MDDT) (Updated)

Medical Device Development Tool (MDDT) Proposal Submission Content (Updated)

Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication

Clinical Laboratory Improvement Amendments (CLIA) (Updated)
- CLIA Categorizations (Updated)
- CLIA Waiver by Application (Updated)

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

At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)

Medical Device Shortages List (Updated)

Supply and Shortages of Medical Devices: Frequently Asked Questions (Updated)

July 13, 2023

Surgical Mesh Used for Hernia Repair (Updated)
- Information for Patients (Updated)
- FDA Activities (Updated)
- Reporting Problems to the FDA (Updated)

CDRH Petitions (Updated)

U.S.-Japan Regulatory Collaboration (Updated)

Class I Recalls:
- NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates
- Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop

Consumer Information: Inspire Upper Airway Stimulation - P130008/S090 (Inspire Medical Systems, Inc.)

Consumer Information: VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) - P130010 (MicroPort CRM)

Federal Register: Charter Amendments, Establishments, Renewals and Terminations: National Mammography Quality Assurance Advisory Committee

July 12, 2023

Breakthrough Devices Program (Updated)

Consumer Information: TactiFlex Ablation Catheter, Sensor Enabled - P220013 (Abbott Medical)

July 11, 2023

MedSun Newsletter - July 2023

Class I Recall: Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients

UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality - Letter to Health Care Providers

Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease (Updated)

July 10, 2023

Revised Emergency Use Authorization
- LumiraDx SARS-CoV-2 RNA STAR Complete (LumiraDX UK LTD)

Consumer Information:
- SKINVIVE by JUVÉDERM – P110033/S059 (Allergan Aesthetics)
- Restylane Eyelight – P040024/S135 (Galderma Laboratories, L.P.)

Electronic Export Documents – Letter to Industry

CDRH Petitions (Updated)

July 7, 2023

Revised Emergency Use Authorization
- UOL COVID-19 Test (Uh-Oh Labs, Inc.)

July 6, 2023

Revised Emergency Use Authorization
- LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay (LumiraDx)

Updated Emergency Use Authorizations
- MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
- ePlex Respiratory Pathogen Panel 2 (GenMark Diagnostics, Inc.)

Dermal Fillers (Soft Tissue Fillers) (Updated)

Automated External Defibrillators (AEDs) (Updated)

July 5, 2023

Updated Emergency Use Authorization
- OHC COVID-19 Antigen Self Test (Osang, LLC.)
- SPERA COVID-19 Ag Test (Xtrava Health)

Revoked Emergency Use Authorization
- CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) (Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard)

MQSA National Statistics (Updated)

July 3, 2023

New Emergency Use Authorization
- Discover Labs COVID-19 Assay (Discover Labs)

Revised Emergency Use Authorization
- Status COVID-19 Antigen Rapid Test for Home Use (Princeton BioMeditech Corp.)

At-Home OTC COVID-19 Diagnostic Tests
- iHealth COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)
- Status COVID-19 Antigen Rapid Test for Home Use (Princeton BioMeditech Corp.)

Updated Emergency Use Authorization
- Lucira CHECK-IT COVID-19 Test Kit (Pfizer Inc.)

eMDR System Enhancements (Updated)

June 29, 2023

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

June 28, 2023

UPDATE: NuVasive Specialized Orthopedics’ Precice Devices - Letter to Health Care Providers

June 27, 2023

Consumer Information: REFLECT Scoliosis Correction System - H210002 (Globus Medical, Inc.)

Patient-Matched Guides to Orthopedic Implants - Draft Guidance for Industry and Food and Drug Administration Staff

June 26, 2023

Teleflex, and Arrow International, Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation and Leakage

Revoked Emergency Use Authorization
- Verily COVID-19 RT-PCR Test (Verily Life Sciences)

Collaborative Communities – Updated with AFDO/RAPS AI Global Healthcare Initiative Collaborative Community

At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar

June 22, 2023

Ventilators and Ventilator Accessories EUAs: Ventilators Removed from Appendix B (Updated)

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force (Updated)

June 21, 2023

Revised Emergency Use Authorizations
- INDICAID COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
- INDICAID COVID-19 Rapid Antigen At-Home Test (PHASE Scientific International, Ltd.)

Meeting Notice: August 22-23, 2023: Circulatory System Devices Panel of the Medical Devices Advisory Committee

June 20, 2023

Revised Emergency Use Authorization
- Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay (Texas Department of State Health Services, Laboratory Services Section)

Oncology Drug Products Used with Certain In Vitro Diagnostics Pilot Program

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210038, DEN210040 and DEN220048 added)

Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)

Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee

Reissued Emergency Use Authorizations
- Lucira COVID-19 All-In-One Test Kit (Lucira Health, Inc.)
- Lucira by Pfizer COVID-19 & Flu Test (Lucira Health, Inc.)
- Lucira by Pfizer COVID-19 & Flu Home Test (Lucira Health, 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 Authorization
- cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)

Revoked Emergency Use Authorization
- BD Veritor At-Home COVID-19 Test (Becton, Dickinson and Company (BD))

June 15, 2023

Updated Emergency Use Authorization
- Xpert Ebola Assay (Cepheid)

June 13, 2023

Reissued Emergency Use Authorization
- ViroKey SARS-CoV-2 RT-PCR Test v2.0 (Vela Operations Singapore Pte. Ltd.)
- OSOM COVID-19 Antigen Home Test (SEKISUI Diagnostics, LLC.)
- OSOM COVID-19 Antigen Rapid Test (SEKISUI Diagnostics, LLC.)

Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff

Webinar - Final Guidance: Content of Premarket Submissions for Device Software Functions - July 20, 2023

Voluntary eSTAR Program (Updated)

Update: Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220078 added)

Federal Register: Content of Premarket Submissions for Device Software Functions

June 12, 2023

Class I Recall: BearCare, Inc. Recalls Rechargeable Walnut Wearable Smart Thermometers for Risks of Serious Injury, including Burns During Use

New Emergency Use Authorization
- In-Dx SARS-CoV-2 RT-LAMP Assay (Michigan State University laboratories, Department of Medicine Olin Student Health Center)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220028 added)

Oxygenator Devices Used for Extracorporeal Circulation - Letter to Health Care Providers

Voluntary eSTAR Program (Updated)

June 8, 2023

New Emergency Use Authorization
- SARS-CoV-2 Acutis Multiplex Assay (Acutis Diagnostics)

Medical Device Shortages List (Updated)

Supply and Shortages of Medical Devices: Frequently Asked Questions (Updated)

June 6, 2023

Revised Emergency Use Authorization
- BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) (Biofire Diagnostics, LLC)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220041, DEN200063, DEN210045 and DEN210046 added)

June 5, 2023

Revoked Emergency Use Authorizations
- Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test
- Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test

Revised Emergency Use Authorizations
- ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics, Inc.)
- Atellica IM SARS-CoV-2 Antigen (CoVAg) (Siemens Healthcare Diagnostics, Inc.)

Class I Recall: Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support

Non-sterile, Single-use Pneumatic Tourniquet Cuffs Conservation Strategies - Letter to Health Care Providers

June 2, 2023

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Guidance for Industry and Food and Drug Administration Staff

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)

MQSA National Statistics (Updated)

June 1, 2023

Revised Emergency Use Authorization
- TaqPath COVID-19 Pooling Kit (Thermo Fisher Scientific Inc.)

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies

Jobs at the Center for Devices and Radiological Health (CDRH)

Current Career Opportunities at CDRH

Why Choose CDRH for Your Career?

Hurricane Emergency Preparedness and Medical Devices: Recommendations for Health Care Providers, Device Manufacturers and Distributors

Consumer Information: Sculptra - P030050/S039 (Q-Med AB)

May 30, 2023

SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)

New Emergency Use Authorization
- Bio-Self COVID-19 Antigen Home Test (BioTeke USA, LLC)

Reissued Emergency Use Authorizations
- SPERA COVID-19 Ag Test (Xtrava Health)
- Quest Diagnostics Mpox Virus Qualitative Real-Time PCR (2-well) (Quest Diagnostics Nichols Institute)

Revised Emergency Use Authorization
- ID NOW COVID-19 2.0 (Abbott Diagnostics Scarborough, Inc.)
- QIAreach SARS-CoV-2 Antigen (QIAGEN GmbH)

Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures - Guidance for Industry and Food and Drug Administration Staff

Laparoscopic Power Morcellators (Updated)

Federal Register: Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures

May 24, 2023

Class I Recall: Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support

May 23, 2023

Consumer Information: xT CDx - P210011 (Tempus Labs, Inc.)

Revised Emergency Use Authorization
- cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular System)

May 22, 2023

Consumer Information: ADVIA Centaur HBc Total 2 (HBcT2), ADVIA Centaur HBc Total 2 Quality Control (HBcT2 QC), Atellica IM HBc Total 2 (HBcT2), Atellica IM HBc Total Quality Control (HBcT2 QC) - P210019/S002 (Siemens Healthcare Diagnostics Inc.)

Class I Recall: ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery

Online 506J Notification Submission Methods: Frequently Asked Questions (Updated)

May 18, 2023

Reissued Emergency Use Authorization
- DTPM COVID-19 RT-PCR Test - (DTPM, Inc.)

Revised Emergency Use Authorization
- Status COVID-19/Flu A&B (Princeton BioMeditech Corp.)
- BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B (Becton, Dickinson and Company (BD)

Updated Emergency Use Authorizations
- Nano-Check COVID-19 Antigen At-Home Test (Nano-Ditech Corporation)

Meeting Notice: September 6, 2023 Patient Engagement Advisory Committee

May 17, 2023

Consumer Information: Precision7, Precision7 for Astigmatism, Precision7 Multifocal, Precision7 Multifocal Toric (serafilcon A) - P220007 (Alcon Laboratories, Inc.)

Consumer Information: MiniMed 780G System - P160017/S091 (Medtronic MiniMed, Inc.)

At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Boson Rapid SARS-CoV-2 Antigen Test

May 16, 2023

New Emergency Use Authorization
- Nano-Check COVID-19 Antigen At-Home Test (Nano-Ditech Corporation)

Reissued Emergency Use Authorization
- Pilot COVID-19 At-Home Test (SD Biosensor, Inc.)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220083 added)

Coronavirus (COVID-19) and Medical Devices

COVID-19 Emergency Use Authorizations for Medical Devices

Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)

At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions

Contacts for Medical Devices Related to COVID-19

Information for Filing Personal Protective Equipment and Medical Devices Relating to COVID-19

Registration and Listing of Medical Devices Relating to COVID-19

Medical Device Supply Chain and Shortages

Medical Device Shortages List

Supply and Shortages of Medical Devices: Frequently Asked Questions

Notify the FDA About a Medical Device Supply Issue

May 10, 2023

Revoked Emergency Use Authorization
- Clip COVID Rapid Antigen Test (Luminostics, Inc.)

Reissued Emergency Use Authorization
- iHealth COVID-19 Antigen Rapid Test Pro (iHealth Labs, Inc.)
- Metrix COIVD-19 Test (Aptitude Medical Systems Inc.)

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

MDUFA Reports
- May 10, 2023 MDUFA V Performance Report
- May 10, 2023 MDUFA IV Performance Report

May 9, 2023

Revised Emergency Use Authorizations
- Atellica IM SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics, Inc.)
- ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics, Inc.)

Consumer Information: Lava Liquid Embolic System – P220020 (BlackSwan Vascular, Inc.)

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)

Federal Register: Emergency Use Authorization: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Revocation

May 8, 2023

In Vitro Diagnostics Emergency Use Authorizations (EUAs) - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2 (Updated)

MedSun Newsletter - May 2023

Transcript: April 20, 2023 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting

Consumer Information: Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management - P210037 (BIOTRONIK NRO, INC.)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210038 and DEN210040 added)

May 5, 2023

Antimicrobial Resistance and Medical Devices

CDRH Learn (Updated)
- Presentation, Transcript, and Printable Slides: Virtual Town Hall Series, Test Development and Validation During the COVID-19 Public Health Emergency, April 26, 2023

MDSAP QMS Procedures and Forms (Updated)

MDSAP QMS Documents (Updated)

May 4, 2023

Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication

New Emergency Use Authorizations
- SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay (Drexel University College of Medicine)
- Global Direct RT-PCR Test (Access Medical Laboratories, Inc.)

Revised Emergency Use Authorizations
- Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC)

Updated Emergency Use Authorizations
- InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.)

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

Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)

Additively Manufactured Mock Spine Cage Designs for Mechanical Performance Test Assessments: STL Set 1

Lumbar Integrated Fixation Devices-Best Practices for Biomechanical Evaluation Under Fatigue Loading

VICTRE: In Silico Breast Imaging Pipeline

Endoscope Geometric Distortion- A Method for Quantitative Evaluation (Updated)

Infrared Thermographs- Methods for Evaluating Laboratory Performance (Updated)

Method for Estimating the Likelihood of Wireless Coexistence (Updated)

Modified Dot-Blot Method to Evaluate Personal Protective Equipment (PPE) (Updated)

Verification Test Problems for Cardiac Electrophysiology Modeling Software (Updated)

May 3, 2023

OTC Hearing Aids: What You Should Know

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210032 and DEN220039 added)

May 1, 2023

New Emergency Use Authorizations
- Princeton BioMeditech Corp Status COVID-19 Antigen Rapid Test for Home Use

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

Cybersecurity (Updated)

MQSA National Statistics (Updated)

Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers

FAQs on Viral Transport Media During COVID-19 (Updated)

24 Hour Summary for April 20, 2023 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting

April 26, 2023

New Emergency Use Authorizations
- ICTC SARS-CoV-2 RT-PCR Assay (University of Massachusetts)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210055, DEN220033, DEN220059 and DEN220085 added)

Consumer Information: NeuRx Diaphragm Pacing System - P200018 (Synapse Biomedical, Inc.)

April 25, 2023

Mammography Facility Adverse Event and Action Report – April 25, 2023: University Park OBGYN, LLC

April 24, 2023

New Emergency Use Authorization
- MedArbor Diagnostics SARS-CoV-2 Assay (MedArbor, LLC dba MedArbor Diagnostics)

Revised Emergency Use Authorizations
- 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)
- LIAISON SARS-CoV-2 Ag (DiaSorin, Inc.)

Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication (Updated)

Federal Register: Authorization of Emergency Use of a Medical Device During COVID-19

Class I Recall: Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics for Risk of Inadequate Ventilation, Other Injuries from Cracked Manifolds

Consumer Information on: Inspire Upper Airway Stimulation - P130008/S089

CDRH Learn
- Presentation and Transcript - Webinar on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

April 19, 2023

Revised Emergency Use Authorization
- The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector (ADL Diagnostics, Inc., dba Anavasi Diagnostics)

Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment

GUDID Data Trends (Updated)

Federal Register: Emergency Use Authorization: In Vitro Diagnostic Devices for Detection and/or Diagnosis of Ebola; Revocation

April 18, 2023

Revised Emergency Use Authorization
- Lyra SARS-CoV-2 Assay (Quidel Corporation)

Revoked Emergency Use Authorizations
- Detect Covid-19 Test (Detect, Inc.)
- OmniPATH COVID-19 Total Antibody ELISA Test (Thermo Fisher Scientific)

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

April 17, 2023

New Emergency Use Authorization
- Azure FaStep® COVID-19 Antigen Pen Home Test (Azure Biotech, Inc.)

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

Jobs at the Center for Devices and Radiological Health (CDRH) (Updated)

CDRH Learn (Updated)
- Printable Slides: Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023

510(k) Third Party Performance Metrics and Accreditation Status (Updated)
- Performance Report - FY23, Q2

Revised Emergancy Use Authorization
- Hotgen COVID-19 Antigen Home Test (Beijing Hotgen Biotech Co., Ltd.)

April 13, 2023

Revised Emergency Use Authorizations
- QuickVue SARS Antigen Test (Quidel Corporation)
- Genabio COVID-19 Rapid Self-Test Kit (Genabio Diagnostics, Inc.)

Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff

FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls (Updated)

UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (Updated)

April 12, 2023

Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for Risk of Extreme Heat and Fire (Updated)

Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication

April 11, 2023

Revised Emergency Use Authorization
- BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)

CDRH Announces Radiation Sterilization Master File Pilot Program

Sterilization for Medical Devices (Updated)

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated

Federal Register: Center for Devices and Radiological Health Radiation Sterilization Master File Pilot Program

April 10, 2023

Federal Register: Medical Devices; Reports of Corrections and Removals

April 7, 2023

Consumer Information: iCAST Covered Stent System – P120003 (Atrium Medical Corporation)

Class I Recall: Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

April 6, 2023

Patient Preference Information (PPI) in Medical Device Decision Making (Updated)

Class I Recall: Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for Risk of Extreme Heat and Fire

Scientific Fellowships at CDRH (Updated)

April 4, 2023

Updated Emergency Use Authorizations
- TaqPath COVID-19 RNase P Combo Kit 2.0 (Thermo Fisher Scientific Inc.)
- InteliSwab COVID-19 Rapid Test Pro (OraSure Technologies, Inc.)

Recognized Consensus Standards (IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION added)

Automated External Defibrillators (AEDs) (added Avive Pad Cartridge - Avive Solutions, Inc.)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200011 added)

Virtual Town Hall - Test Development and Validation During the COVID-19 Public Health Emergency - April 26, 2023

April 3, 2023

MQSA National Statistics (Updated)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210039 and DEN220030 added)

Updated Emergency Use Authorizations
- ARIES SARS-CoV-2 Assay (Luminex Corporation)
- STANDARD M nCoV Real-Time Detection Kit (SD Biosensor, Inc)
- Xpert Mpox (Cepheid)

Revised Emergency Use Authorizations
- LumiraDx SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
- Sampinute COVID-19 Antigen MIA (Celltrion USA, Inc.)
- Bio-Speedy Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Inc.)
- Sofia 2 Flu + SARS Antigen FIA (Quidel Corporation)
- Sienna-Clarity COVID-19 Antigen Rapid Test Cassette (Salofa Oy)
- NIDS COVID-19 Antigen Rapid Test Kit (ANP Technologies, Inc.)
- QuickVue At-Home COVID-19 Test (Quidel Corporation)

Consumer Information: RelayPro Thoracic Stent-Graft System - P200045/S002 (Bolton Medical, Inc.)

Consumer Information: CALCIVIS Imaging System - P170029 (CALCIVIS Limited)

Consumer Information: VENTANA PD-L1 (SP263) Assay - P160046/S013 (Ventana Medical Systems, Inc.)

Problems Reported with Essure (Updated

FDA Activities Related to Essure (Updated)

Expiration Dates Extended for Three OTC COVID-19 At-Home Tests (OHC COVID-19 Antigen Self Test, Flowflex COVID-19 Antigen Home Test, InteliSwab COVID-19 Rapid Test)

Class I Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After PCBA Communication Loss

March 30, 2023

Revised Emergency Use Authorizations
- SARS-CoV-2 Assay (Integrity Laboratories)
- Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay (Texas Department of State Health Services, Laboratory Services Section)

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions - Draft Guidance for Industry and Food and Drug Administration Staff

CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices

Webinar - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning-Enabled Device Software Functions Draft Guidance - April 13, 2023

Evaluation of Safety Concerns with Certain Dental Devices Used on Adults – FDA Safety Communication

Medical Device Development Tool (MDDT)
- New tool: Computational Tool Comprising Visible Human Project Based Anatomical Female CAD Model and Ansys HFSS/Mechanical FEM Software for Temperature Rise Prediction near an Orthopedic Femoral Nail Implant during a 1.5 T MRI Scan

March 29, 2023

Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act - Guidance for Industry and Food and Drug Administration Staff

Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)

Cybersecurity (Updated)

Voluntary eSTAR Program (Updated)

Federal Register: Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures

Federal Register: Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures

Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension: M6-C Artificial Cervical Disc

Federal Register: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems under the Federal Food, Drug, and Cosmetic Act

March 28, 2023

Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff

Revised Emergency Use Authorizations
- C-Sync COVID-19 Antigen Test (Biosynchronicity Corporation)

Federal Register: Premarket Approval of Medical Devices

Federal Register: Testing Communications by the Center for Devices and Radiological Health

Federal Register: Orthopedic Non-Spinal Bone Plates, Screws, and Washers-Premarket Notification (510(k)) Submissions

March 27, 2023

CLIA Waived - Sysmex XW-100 CW210002 (Updated)

New Emergency Use Authorizations
- C-Sync COVID-19 Antigen Test (Biosynchronicity Corporation)

Revised Emergency Use Authorizations
- InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.)
- InteliSwab COVID-19 Rapid Test Pro (OraSure Technologies, Inc.)
- InteliSwab COVID-19 Rapid Test Rx (OraSure Technologies, Inc.)

Reissued Emergency Use Authorizations
- Biomeme SARS-CoV-2 Real-Time RT-PCR Test (Biomeme, Inc.)

General Considerations for Animal Studies Intended to Evaluate Medical Devices - Guidance for Industry and Food and Drug Administration Staff

Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff

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 - March 22, 2023

Federal Register: Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway

Federal Register: General Considerations for Animal Studies Intended to Evaluate Medical Devices

Reissued Emergency Use Authorizations
- Visby Medical Respiratory Health Test (Visby Medical, Inc.)
- PerkinElmer New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)

Revised Emergency Use Authorizations
- Lucira COVID-19 & Flu Test (Lucira Health, Inc.)
- Lucira COVID-19 & Flu Home Test(Lucira Health, Inc.)
- UTHSC/UCH SARS-CoV-2-RT-PCR Assay (UTMG Pathology Laboratory)

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff

Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff

Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023

FDA Issues Final Guidances to Assist with Transition Plans for COVID-19-Related Medical Devices

FAQs on Emergency Use Authorizations (EUAs) for Medical Devices Related to COVID-19 (Updated)

Importing Medical Devices Relating to COVID-19 (Updated)

Diagnostic Data Program

Federal Register: Transition Plan for Medical Devices Issued Emergency Use Authorizations Related to Coronavirus Disease 2019

Federal Register: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency

March 23, 2023

Reissued Emergency Use Authorization
- NIDS COVID-19 Antigen Rapid Test Kit (ANP Technologies, Inc.)

Updated Emergency Use Authorizaiton
- Flowflex COVID-19 Antigen Home Test (ACON Laboratories, Inc.)

SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)

Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety Communication

March 22, 2023

CorDx COVID-19 Ag Test (CorDX, Inc.)

MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)

Status COVID-19/Flu A&B (Princeton BioMeditech Corp.)

BD Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson and Company (BD))

ePlex Respiratory Pathogen Panel (GenMark Diagnostics, Inc.)

TaqPath COVID-19 Fast PCR Combo Kit 2.0 (Life Technologies Corporation)

TaqPath COVID-19, FluA, FluB Combo Kit (Thermo Fisher Scientific)

March 21, 2023

New Emergency Use Authorization
- Cue Mpox (Monkeypox) Molecular Test (Cue Health, Inc.)

March 20, 2023

Send and Track Medical Device Premarket Submissions Online: CDRH Portal (Updated)

Pediatric X-ray Imaging (Updated)

Microwave Ovens (Updated)

Federal Register: Medical Devices: Technical Amendments

Revised Emergency Use Authorizations
- VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho-Clinical Diagnostics, Inc.)

Reissued Emergency Use Authorizations
- COV-19 IDx assay (Ipsum Diagnostics, LLC)
- Accula SARS-Cov-2 Test (Mesa Biotech Inc.)

March 22 Will Be the Last Recurring Virtual Town Hall in the Series on Test Development and Validation During Public Health Emergencies – Mpox and COVID-19External Link Disclaimer

Class I Recall: Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown Coiled Cord Connection Failure

March 16, 2023

Revised Emergency Use Authorizations
- Flowflex COVID-19 Antigen Home Test (ACON Laboratories Inc)
- CareStart COVID-19 Antigen Home Test (Access Bio, Inc.)

Reissued Emergency Use Authorizations
- OHC COVID-19 Antigen Self Test (OSANG LLC)

Updated Emergency Use Authorizations
- Ejection Fraction Tool (ELEFT) (Anumana, Inc.)

Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)

March 15, 2023

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)

March 14, 2023

Revoked Emergency Use Authorizations
- Idylla Ebola Virus Triage Test (Biocartis NV)
- FilmArray NGDS BT-E Assay (BioFire Defense, LLC)

Reissued Emergency Use Authorizations
- Quest SARS-CoV-2 rRT-PCR (Quest Diagnostics Nichols Institute)
- Quest Diagnostics PF SARS-CoV-2 Assay (Quest Diagnostics Nichols Institute)
- Quest Diagnostics RC SARS-CoV-2 Assay (Quest Diagnostics Nichols Institute)

Revised Emergency Use Authorizations
- Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (Co-Diagnostics, Inc.)

March 13, 2023

New Emergency Use Authorization
- Quest COVID-19 Nucleic Acid Test Collection Kit (Quest Diagnostics Nichols Institute)

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

Public Workshop - Appropriate Use of Consensus Standards - 12/07/2022 (Transcript Added)

Joint Public Workshops - Medical Devices for Opioid Use - 11/07-08/2022 (Transcript Added)

Consumer Information on Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System - P160043/S058 (Medtronic Vascular)

Revised Emergency Use Authorization
- SARS-CoV-2 Fluorescent PCR Kit (Maccura Biotechnology (USA) LLC)

Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff

Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff

March 9, 2023

Reissued Emergency Use Authorizations
- Flowflex COVID-19 Antigen Home Test (ACON Laboratories, Inc.)
- CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) (Centers for Disease Control and Prevention)

Revised Emergency Use Authorizations
- SARS-CoV-2 PCR test (Yale New Haven Hospital, Clinical Virology Laboratory)
- MicroGen DX COVID-19 Key (Southwest Regional PCR Laboratory LLC.)

Frequently Asked Questions About MQSA (Updated)

Federal Register: Mammography Quality Standards Act

Federal Register: Emergency Use Authorization: Certain Medical Devices during COVID-19

Federal Register: In Vitro Diagnostic Device in Response to an Outbreak of Mpox

March 8, 2023

Consumer Information on StableVisc and TotalVisc Ophthalmic Viscosurgical Device - P220009 (Bausch Health Companies, Inc.)

Updated Emergency Use Authorization
- BD Veritor At-Home COVID-19 Test (Becton, Dickinson and Co.)

In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 (Updated)

In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2 (Updated)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210033 and DEN220039 added)

UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication

CDRH Statement: CDRH Updates Safety Communication for Squamous Cell Carcinoma (SCC) in Scar Tissue around Breast Implants

Federal Register: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability

March 7, 2023

CDRH Statement on Emergency Use Authorization of Lucira Health’s COVID-19 & Flu Home Test

Meeting Notice: April 20, 2023 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

CDRH's Experiential Learning Program (Updated)

Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers

March 6, 2023

Revised Emergency Use Authorizations
- Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
- Celltrion DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
- Sofia SARS Antigen FIA (Quidel Corporation)
- VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho Clinical Diagnostics, Inc.)
- Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.)

Reissued Emergency Use Authorizations
- Umbrella EUA for Surgical Masks

Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19 (Updated)

Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

March 3, 2023

Updated Emergency Use Authorizations
- LabGun COVID-19 RT-PCR Kit (LabGenomics Co., Ltd.)

Reissued Emergency Use Authorizations
- Everlywell COVID-19 Test Home Collection Kit DTC (Everlywell, Inc.)
- Everlywell COVID-19 Test Home Collection Kit (Everlywell, Inc.)

Revised Emergency Use Authorizations
- Genetron SARS-CoV-2 RNA Test (Genetron Health (Beijing) Co., Ltd)

At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Speedy Swab Rapid COVID-19 Ag Self-Test (Watmind USA) - extended expiration dates

Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar (Actualizado)
- COVID-19 y prueba casera de la gripe de Lucira (Lucira Health, Inc.)
- Autodiagnóstico COVI-Go SARS-CoV-2 Ag (Mologic, Inc.)
- Prueba casera de GenBody para el COVID-19 Ag (GenBody Inc.)
- Prueba auto-diagnóstico rápido del antígeno CLINITEST para el COVID-19 (Siemens Healthineers)

March 2, 2023

MDUFA Reports
- March 1, 2023 MDUFA V Performance Report
- March 1, 2023 MDUFA IV Performance Report

MQSA National Statistics (Updated)

March 1, 2023

Updated Emergency Use Authorization
- CDC Novel Coronavirus 2012 Real-time RT-PCR Assay (Centers for Disease Control and Prevention)
- OHC COVID-19 Antigen Self Test (OSANG LLC)

Total Product Life Cycle Advisory Program (TAP) (Updated)

Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced - Letter to Health Care Providers

Federal Register: Requests for Nominations - Patient Engagement Advisory Committee

February 27, 2023

Revised Emergency Use Authorization
- LumiraDx SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
- SARS-CoV-2 Test Kit (Real-time PCR) (Xiamen Zeesan Biotech Co., Ltd.)
- GenBody COVID-19 Ag (GenBody Inc.)
- ASSURE-100 Rapid COVID-19 Test (Oceanit Foundry LLC)
- GeneFinder COVID-19 Plus RealAmp Kit (OSANG Healthcare)

Adult Portable Bed Rail Safety (Updated)

Safety Concerns about Adult Portable Bed Rails (Updated)

Recommendations for Consumers and Caregivers about Adult Portable Bed Rails (Updated)

Recommendations for Health Care Providers Using Adult Portable Bed Rails (Updated)

Information for Manufacturers of Bed Rail Products (Updated)

How to Report a Problem or Complaint about Bed Rails (Updated)

Bed Rail Safety Activities (Updated)

Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration- Letter to Health Care Providers

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220063 added)

New Emergency Use Authorization
- Lucira COVID-19 & Flu Home Test (Lucira Health, Inc.)

Revised Emergency Use Authorization
- Speedy Swab Rapid COVID-19 Antigen Self-Test (Watmind USA)

Updated Emergency Use Authorization
- LumiraDx SARS-CoV-2 RNA STAR (LumiraDx UK Ltd.)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220065 added)

February 23, 2023

Revised Emergency Use Authorizations
- cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems)
- cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems)

Consumer Information on: Guardant360 CDx - P200010/S010

Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers

Center for Devices and Radiological Health (CDRH) Compliance Programs (Updated)
- Inspection and Field Testing of Radiation-Emitting Electronic Products (CPMG 7386.001)
- Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment (CPMG 7386.003a)

Update: Reduce the Risk for Medical Device Misconnections

February 22, 2023

New Emergency Use Authorization
- COVI-Go SARS-CoV-2 Ag Self-Test (Mologic, Inc.)

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

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210022 added)

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 - February 15, 2023

ASCA-Accredited Testing Laboratories (Updated)

February 21, 2023

New Emergency Use Authorization
- GenBody COVID-19 Ag Home Test (GenBody Inc.)

Revised Emergency Use Authorization
- DxTerity SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.)

Reissued Emergency Use Authorizations
- Ellume COVID-19 Home Test (Ellume Limited)
- CLINITEST Rapid COVID-19 Antigen Self-Test (Siemens Healthineers)

Terminated Emergency Use Authorization
- EV-D68 2014 rRT-PCR

Appendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Updated)

Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) - Guidance for Industry and Food and Drug Administration Staff

Medical X-Ray Imaging Devices Conformance with IEC Standards - Guidance for Industry and Food and Drug Administration Staff

Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices - Guidance for Industry and Food and Drug Administration Staff

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff

Assembler's Guide to Diagnostic X-Ray Equipment - Guidance for Industry and Food and Drug Administration Staff

Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff

Medical X-ray Imaging (Updated)

Does the Product Emit Radiation? (Updated)

Fluoroscopy (Updated)

Updated Emergency Use Authorization
- QuickVue At-Home OTC COVID-19 Test (Quidel Corporation)

Network of Experts Program: Connecting the FDA with External Expertise (Updated)

February 16, 2023

Revised Emergency Use Authorizations
- AMPIPROBE SARS-CoV-2 Test System (Enzo Life Sciences, Inc.)
- Metrix COVID-19 Test 2.0 (Aptitude Medical Systems Inc.)
- ellume.lab COVID Antigen Test (Ellume Limited)
- Genetrack SARS-CoV-2 Molecular Assay (Genetrack Biolabs, Inc.)

Revoked Emergency Use Authorizations
- SARS-CoV-2 NGS Assay (Twist Bioscience Corporation)
- Babson Diagnostics aC19G1 (Babson Diagnostics, Inc.)

February 15, 2023

Revised Emergency Use Authorizations
- Aptima SARS-CoV-2/Flu assay (Hologic, Inc.)
- Fosun COVID-19 RT-PCR Detection Kit (Fosun Pharma USA Inc.)

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

For consumer information: Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems - P010032/S189 (Abbott Medical)

Class I Recall: GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems for Risk of Detector Fall That May Injure Patients

February 14, 2023

Revised Emergency Use Authorization
- The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector (ADL Diagnostics, Inc., dba Anavasi Diagnostics)
- cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)

February 13, 2023

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

Nucleic Acid Based Tests (Updated)

Federal Register: Medical Device Labeling Requirements; Unique Device Identification

New Emergency Use Authorizations
- BU SARS-CoV-2 Test (The HFI Laboratory at Boston University (dba the BU Clinical Testing Laboratory))
- Xpert Mpox (Cepheid)

CDRH Petitions (Updated)

February 9, 2023

Updated Emergency Use Authorization
- cobas SARS-CoV-2 (Roche Molecular Systems Inc.)
- BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)

Medical Device Material Safety Summaries (Updated)

Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)

Extended Expiration Date: CareStart COVID-19 Antigen Home Test and On/go COVID-19 Self-Test

Personal Protective Equipment EUAs - Appendix A: Authorized Surgical Masks (Updated)

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)

February 8, 2023

New Emergency Use Authorization
- The AscencioDx COVID-19 Test Kit and The AscencioDx Molecular Detector (ADL Diagnostics, Inc., dba Anavasi Diagnostics)

Personal Protective Equipment EUAs - Appendix A: Authorized Surgical Masks (Updated)

Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA

February 7, 2023

New Emergency Use Authorizations
- BD Respiratory Viral Panel for BD MAX System (Becton, Dickinson and Company (BD))
- LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay (LumiraDx UK Ltd.)

Revised Emergency Use Authorization
- NxTAG Respiratory Pathogen Panel + SARS-CoV-2 (Luminex Molecular Diagnostics, Inc.)

CDRH Petitions (Updated)

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

Mammography Facility Adverse Event and Action Report – February 7, 2023: Advanced Women Imaging

Mammography Facilities with Revoked MQSA Certificate (Advanced Women Imaging 02-07-23)

Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ

February 6, 2023

Medical Devices Resources for Consumers (Updated)

Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220044 added)

February 3, 2023

Revised Emergency Use Authorization
- CareStart COVID-19 Antigen Home Test (Access Bio, Inc.)

510(k) Third Party Performance Metrics and Accreditation Status (Updated)
- Performance Report - FY23, Q1

February 2, 2023

Revoked Emergency Use Authorizations
- Advanta Dx SARS-CoV-2 RT-PCR Assay (Standard BioTools Inc.)
- Advanta Dx COVID-19 EASE Assay (Standard BioTools Inc.)
- BinaxNOW COVID-19 Ag 2 Card (Abbott Diagnostics Scarborough, Inc.)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220014 added)

Accreditation Scheme for Conformity Assessment (ASCA) 2022 Annual Report

MedSun Newsletter - February 2023

February 1, 2023

For Consumer information: FlexAbility Abalation Catheter, Sensor Enabled - P110016/S080 (Abbott Medical)

CDRH's Experiential Learning Program (Updated)

Historical Information about Device Emergency Use Authorizations (Updated)

MQSA National Statistics (Updated)

Federal Register: Hematology and Pathology Devices; Classification of the Software Algorithm Device to Assist Users in Digital Pathology

Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

January 30, 2023

Class I Recall: Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect

Surveying, Leveling, and Alignment Laser Products - Guidance for Industry and Food and Drug Administration Staff

Federal Register: Surveying, Leveling, and Alignment Laser Products

Federal Register: Cardiovascular Devices; Classification of the Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate

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

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

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.)

ASCA-Recognized Accreditation Bodies (Updated)

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

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)