|
|
| Fresenius
Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies
That Have the Potential to Cause Serious Patient Harm or Death
04/17/2024 |
| Boston
Scientific Recalls Obsidio Conformable Embolic for Increased Bowel
Ischemia Risk When Used for Lower GI Bleeding 04/17/2024 |
| Abbott/Thoratec
Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist
System (LVAS) due to Long-term Buildup Causing an Obstruction
04/15/2024 |
| Medos
International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath
due to Cracking of the Distal Catheter Shaft 04/04/2024 |
| Smiths
Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator Kits
for a Malfunction Causing Non-Cycling, Continuous Positive Gas Flow
and Preventing Proper Ventilation 04/04/2024 |
| Teleflex
and Arrow International Recall ARROW QuickFlash Radial Artery and
Radial Artery/Arterial Line Catheterization Kits for Increased Resistance
That May Lead to Vessel Injuries, Narrowing, or Blockage 04/03/2024 |
| Medline
Industries Recalls Certain Kits and Trays Containing Sterile Water
Based Products Under Recall by Nurse Assist 03/25/2024 |
| Vyaire
Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing
Defect That Can Lead to Injury or Death 03/21/2024 |
| Abiomed
Recalls the Instructions for Use for Impella Left Sided Blood Pumps
due to Perforation Risks 03/21/2024 |
| Avanos
Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile
Water Based Products Under Recall by Nurse Assist 03/14/2024 |
| Abbott
Recalls HeartMate Touch Communication System for Unintentional Pump
Start and Stop 03/11/2024 |
| Windstone
Medical Packaging, Inc. Recalls Local Lower Extremity Pack, In House
Ocular Pack and Closure Kit Containing Sterile Water Based Products
Under Recall by Nurse Assist 03/11/2024 |
| Ventec
Life Systems Recalls VOCSN Patient Breathing Package (Pediatric, Active,
Oxygen, Blue) for Manufacturing Issue with Bonded Spiral Wrap
03/07/2024 |
| Medtronic
Neurosurgery Recalls Duet External Drainage and Monitoring System
Catheter Tubing due to a Potential for the Catheter Disconnection
from the Patient Line Stopcock Connectors 03/07/2024 |
| Baxter
Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 Due to a Software
Error 03/06/2024 |
| Smiths
Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to
Issues Associated with Earlier Software Versions 03/05/2024 |
| Datex-Ohmeda
Recalls EVair Air Compressors Due to Formaldehyde Emissions Found
in Specific Conditions When Used with CARESCAPE R860, Engstrom Carestation
or Pro Ventilators 03/01/2024 |
| Wipro
GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000
and Lullaby Incubators Due to Problems with Door Latch 02/29/2024 |
| Olympus
Corporation of the Americas Recalls Laser-Compatible Olympus Bronchoscopes
for Risk of Endobronchial Combustion and Patient Burns 02/28/2024 |
| Philips
Recalls BrightView Imaging Systems Due to the Detector Unexpectedly
Falling 02/15/2024 |
| Smiths
Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to
Issues Associated with Earlier Software Versions 02/14/2024 |
| Percussionaire
Recalls High Frequency Transport Phasitron Breathing Circuit Kits
for Over-Pressurization 02/06/2024 |
| Maquet
Cardiovascular, LLC Recalls Atrium Express Dry Suction Dry Seal Chest
Drain Containing Sterile Water Based Products Under Recall by Nurse
Assist 01/31/2024 |
| Globus
Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration
Fixture Due to a Calibration Error 01/30/2024 |
| ROi
CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to
Possible Lack of Sterility 01/16/2024 |
| Fresenius
Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix
Infusion System Due to Mechanical Interference 01/12/2024 |
| ResMed
Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with
Magnets due to Possible Magnetic Interference with Certain Medical
Devices 01/11/2024 |
| Busse
Hospital Disposables, Inc. Recalls Care Trays and Kits Containing
Sterile Water Based Products Under Recall by Nurse Assist 01/11/2024 |
| Megadyne
Medical Products, Inc. Recalls Mega Soft Universal Patient Return
Electrode Due to Reports of Patient Burns 01/08/2024 |
| 2024
Medical Device Recalls 01/08/2024 |
| Insulet
Corporation Recalls Omnipod 5 Android App due to a Software Error
01/08/2024 |
| 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 12/20/2023 |
| Olympus
Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes
Because They Can Lead to Burns and Fire 12/19/2023 |
| Medtronic
Navigation Inc. Recalls StealthStation S8 Application Version 2.0
and 2.0.1 Due to a Software Glitch 12/19/2023 |
| Getinge
Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability
to Turn the Drive 12/08/2023 |
| Cordis
US Corp Recalls INFINITI Angiographic Catheter due to Products Being
Shipped Without Undergoing Sterilization Procedures 12/05/2023 |
| Becton
Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to
Compatibility Issues with Cardinal Health Monoject Syringes 12/01/2023 |
| Eitan
Medical Ltd Recalls Sapphire Infusion Pumps for Failure to Detect
Air in the Line 12/01/2023 |
| Unomedical
A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector
Piece Causing Unexpected Disconnections 11/27/2023 |
| 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 11/17/2023 |
| Asensus
Surgical Inc. Recalls Senhance Surgical System Due to Malfunctions
with Unintended Movement of the Robotically-Assisted Surgical Device
11/16/2023 |
| Fresenius
Medical Care Recalls Sanxin Single Use Syringes for Leakages 11/15/2023 |
| Baxter
Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential
Underdosing 11/15/2023 |
| Cardinal
Health Recalls Monoject Disposable Syringes for Incompatibilities
with Syringe Pumps 11/14/2023 |
| Covidien
LLC Recalls McGRATH MAC Video Laryngoscope Due to Stolen Defective
Products 11/13/2023 |
| Teleflex,
and Arrow International, Recall Pressure Injectable Catheter Kits
for Mislabeling 11/06/2023 |
| Olympus
Recalls Olympus High Flow Insufflation Unit Due to Over-Inflation
10/30/2023 |
| Fresenius
Medical Care Recalls Some Hemodialysis Machines for Potential Exposure
to Toxic Compounds 10/24/2023 |
| Philips
Respironics Recalls V60 and V60 Plus Ventilators due to Power Management
Printed Circuit Board Assemblies (PM PCBAs) Not Meeting Ventilator
Standards 10/20/2023 |
| Hamilton
Medical Inc. Recalls HAMILTON-C1, T1, MR-1 Ventilators for Capacitator
Leaks and Short Circuits 10/18/2023 |
| Medline
Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal
Saline Solution Due to Being Non-Sterile 09/20/2023 |
| Abbott
Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic
Resonance Imaging (MRI) Mode 09/13/2023 |
| Mallinckrodt
Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening
Properly 09/12/2023 |
| Getinge/Maquet/Datascope
Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs)
for Power Failures When Device is Unseated from Cart 08/31/2023 |
| Getinge/Maquet/Datascope
Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs)
for System Over Temperature Alarms Causing Pump Stops 08/31/2023 |
| Getinge/Maquet/Datascope
Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs)
for Gas Loss and Gas Gain Failures 08/31/2023 |
| Getinge/Maquet/Datascope
Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs)
for Autofill Failure Alarms Resulting in Pump Stops 08/31/2023 |
| Hamilton
Medical Inc. Recalls HAMILTON-C1, C2, C3, T1 Ventilators for Software
Issues that May Cause Ventilators to Stop Without Notice 08/30/2023 |
| Draeger
Recalls Carina Sub-Acute Care Ventilators for Contaminants in Airpath
08/23/2023 |
| Abiomed
Recalls the Labeling for Impella RP Flex with SmartAssist for Risk
of Blood Clots 08/17/2023 |
| 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 08/17/2023 |
| 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 08/14/2023 |
| Datascope/Maquet/Getinge
Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs)
for Unexpected Shutdowns 08/10/2023 |
| 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 07/31/2023 |
| GE
HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce
Defibrillation Energy, Expose Patients to Unintended Voltage, or Give
Inaccurate Readings 07/28/2023 |
| Abiomed
Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage
After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent
07/27/2023 |
| Abbott
Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of
Air Embolism 07/26/2023 |
| 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
07/18/2023 |
| Quidel
Cardiovascular Inc. Recalls Quidel Triage Cardiac Panels for Risk
of False Negative Troponin Results that Could Cause Delayed Diagnosis
or Missed Myocardial Infarction 07/17/2023 |
| Draeger
Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators
for Risk of Unexpected Depleted Battery and Ventilator Stop 07/13/2023 |
| NOxBOX
Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that
May Cause Gas Leaks and Interrupt Therapy to Neonates 07/13/2023 |
| Megadyne
Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes
for Risk of Serious Burn Injuries to Patients 07/11/2023 |
For the most up to date FDA headlines, see the FDA
Medical Device News page.
| April 19, 2024
Updated Emergency Use Authorization
- The
AscencioDx COVID-19 Test and The AscencioDx Molecular Detector (ADL
Diagnostics, Inc., dba Anavasi Diagnostics)
Revoked Emergency Use Authorization
- FTD
SARS-CoV-2 (Fast Track Diagnostics Luxembourg S.à.r.l.)
Risks
with Exactech Equinoxe Shoulder System with Defective Packaging
- FDA Safety Communication (Updated)
|
|
April 17, 2024
CDRH
Statement: CDRH Issues 2024 Safety and Innovation Reports
Medical
Device Safety and Innovation Reports (Updated)
Current
Career Opportunities at CDRH (Updated)
Class
I Recall: Boston Scientific Recalls Obsidio Conformable Embolic
for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding
Class
I Recall: Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP
Software for Anomalies That Have the Potential to Cause Serious
Patient Harm or Death
|
|
April 16, 2024
CDRH
Unveils New Dataset to Help Improve Chemical Characterization Methods
for Biocompatibility of Medical Devices
Manufacturer
and User Facility Device Experience (MAUDE) (Updated)
CDRH
Petitions (Updated)
|
|
April 15, 2024
Revised Emergency Use Authorization
- Aptitude
Medical Systems Inc.: Metrix COVID-19 Test
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Class
I Recall: Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate
3 Left Ventricular Assist System (LVAS) due to Long-term Buildup
Causing an Obstruction
Medical
Device Sterilization Town Hall: Topics and Formats for the Continuing
Sterilization Series, April 29, 2024
Sterilization
for Medical Devices (Updated)
|
| April 11, 2024
MedSun
Newsletter - April 2024
Stress
Urinary Incontinence: Surgical Mesh Considerations and Recommendations
(Updated)
|
|
April 10, 2024
New Emergency Use Authorization
- CorDx
TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
FDA
Activities Related to Recalled Philips Ventilators, BiPAP Machines,
and CPAP Machines (Updated)
Foam
Testing Summary for Recalled Philips Ventilators, BiPAP Machines,
and CPAP Machines (Updated)
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
ASCA-Accredited
Testing Laboratories (Updated)
|
|
April 9, 2024
Problems
Reported With Essure (Updated)
Information
for Patients and Health Care Providers: Essure (Updated)
FDA
Activities Related to Essure (Updated)
|
|
April 8, 2024
New Emergency Use Authorization
- QuickFinder
COVID-19/Flu Antigen Self Test (OSANG LLC)
Re-issued Emergency Use Authorizations
- ePlex
Respiratory Pathogen Panel (GenMark Diagnostics, Inc.)
|
|
April 4, 2024
New Emergency Use Authorization
- SalivaNow
SARS-CoV-2 Assay (LMSI, LLC d/b/a Lighthouse Lab Services)
ASCA-Accredited
Testing Laboratories (Updated)
Class
I Recall:
Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator
Kits for a Malfunction Causing Non-Cycling, Continuous Positive
Gas Flow and Preventing Proper Ventilation
Class
I Recall: Medos International Sàrl Recalls Cerenovus CEREBASE
DA Guide Sheath due to Cracking of the Distal Catheter Shaft
Federal
Register: Device Good Manufacturing Practice Advisory Committee
Federal
Register: Voting Members for the Patient Engagement Advisory Committee
|
|
April 3, 2024
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Class
I Recall: Teleflex and Arrow International Recall ARROW QuickFlash
Radial Artery and Radial Artery/Arterial Line Catheterization Kits
for Increased Resistance That May Lead to Vessel Injuries, Narrowing,
or Blockage
Reports
to Congress (Updated)
- FY 2021 Premarket Approval of Pediatric Uses of Devices
Medical
Device Development Tools (MDDT) (Updated)
|
|
April 2, 2024
Current
Career Opportunities at CDRH (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries - Sleep Apnea
Feature - DEN230041
|
|
April 1, 2024
CDRH
Learn (Updated)
- Presentation and Transcript for Medical Device Sterilization Town
Hall: The Value and Use of Recognized Consensus Standards in Premarket
Submissions - March 21, 2024
Standards
Newsletter from the Division of Standards and Conformity AssessmentExternal
Link Disclaimer
MQSA
National Statistics (Updated)
|
| March 29, 2024
eSTAR
Program (Updated)
|
|
March 28, 2024
Animal
Studies for Dental Bone Grafting Material Devices - Premarket Notification
(510(k)) Submissions - Draft Guidance for Industry and Food and
Drug Administration Staff
Co-sponsored
Public Meeting - Food and Drug Administration/Medical Device Innovation
Consortium Symposium on Computational Modeling and Simulation -
April 16-17, 2024
Mammography
Quality Standards Act and Program (Updated)
Mammography
Quality Standards Act - Facility Accreditation and Certification
(Updated)
Mammography
Quality Standards Act - Inspection Resources
Federal
Register: Animal Studies for Dental Bone Grafting Material Devices
- Premarket Notification (510(k)) Submissions
|
|
March 27, 2024
ASCA
Consolidated Pilot Final Report and 2023 Annual Report
Evaluation
of Automatic Class III Designation (De Novo) Summaries - Invitae
Common Hereditary Cancers Panel (DEN210011)
|
|
March 26, 2024
New Emergency Use Authorizations
- Labcorp
Monkeypox PCR Test Home Collection Kit (LabCorp)
- Non-variola
Orthopoxvirus Real-time PCR Primer and Probe Set - EUA (Centers
for Disease Control and Prevention (CDC))
Evaluation
of Automatic Class III Designation (De Novo) Summaries - Body Temperature
Software (BTS) (DEN230050), Sonu (DEN230045), X100 with Full Field
Bone Marrow Aspirate (BMA) Application, X100HT with Full Field Bone
Marrow Aspirate (BMA) Application (DEN230034)
Total
Product Life Cycle Advisory Program (TAP) (Updated)
|
|
March 25, 2024
CDRH
Statement: FDA Proposes New Ban of Electrical Stimulation Devices
for Self-Injurious or Aggressive Behavior
Medical
Device Bans (Updated)
Class
I Recall: Medline Industries Recalls Certain Kits and Trays Containing
Sterile Water Based Products Under Recall by Nurse Assist
24
Hour Summary and Presentations for March 21, 2024 Ophthalmic Devices
Panel of the Medical Devices Advisory Committee Meeting
Federal
Register: Banned Devices: Proposal to Ban Electrical Stimulation
Devices for Self-Injurious or Aggressive Behavior
|
| March 21, 2024
Class
I Recall: Abiomed Recalls the Instructions for Use for Impella Left
Sided Blood Pumps due to Perforation Risks
Class
I Recall: Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators
Due to Manufacturing Defect That Can Lead to Injury or Death
Breakthrough
Devices Program (Updated)
|
|
March 20, 2024
New Emergency Use Authorization
- EZ-SARS-CoV-2
Real-Time RT-PCR (Tetracore, Inc.)
Transcript
and Summary Minutes for February 13, 2024 Circulatory System Devices
Panel of the Medical Devices Advisory Committee Meeting
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
Federal
Register: Voluntary Total Product Life Cycle Advisory Program Pilot
|
|
March 19, 2024
CDRH
Statement: FDA Provides Update on Plastic Syringes Made in China,
Issues Warning Letters Related to Violative Products
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication
Materials
for March 21, 2024 Ophthalmic Devices Panel of the Medical Devices
Advisory Committee Meeting
|
|
March 18, 2024
Co-sponsored
Public Conference – Food and Drug Administration/Advanced Medical
Technology Association Medical Device Statistical Issues - April
2-3, 2024
|
| March 15, 2024
Artificial
Intelligence and Machine Learning in Software as a Medical Device
(Updated)
Consumer Information: Belotero
Balance® (+) - P090016/S050
(Merz North America, Inc.)
|
|
March 14, 2024
Evaluation
of Thermal Effects of Medical Devices that Produce Tissue Heating
and/or Cooling - Guidance for Industry and Food and Drug Administration
Staff
Requests
for Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program - Draft Guidance for Industry and Food and Drug Administration
Staff
Medical
Device Sterilization Town Hall: The Value and Use of Recognized
Consensus Standards in Premarket Submissions - March 21, 2024
Sterilization
for Medical Devices (Updated)
Class
I Recall: Avanos Recalls MIC Gastric – Jejunal Feeding Tube
Kits Containing Sterile Water Based Products Under Recall by Nurse
Assist
Federal
Register: Medical Devices; Technical Amendments
Federal
Register: Evaluation of Thermal Effects of Medical Devices That
Produce Tissue Heating and/or Cooling
Federal
Register: Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program
|
|
March 13, 2024
Federal
Register: Select Updates for the Premarket Cybersecurity Guidance:
Section 524B of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry and Food and Drug Administration Staff
|
|
March 12, 2024
Select
Updates for the Premarket Cybersecurity Guidance: Section 524B of
the FD&C Act - Draft Guidance for Industry and Food and Drug
Administration Staff
Webinar
- Draft Guidance: Select Updates for the Premarket Cybersecurity
Guidance: Section 524B of the FD&C Act - April 30, 2024
Cybersecurity
(Updated)
|
|
March 11, 2024
CDRH
Statement: CDRH Welcomes 25th Session of the International Medical
Device Regulators Forum
Collaborative
Communities: Addressing Health Care Challenges Together (Updated)
Class
I Recall: Windstone Medical Packaging, Inc. Recalls Local Lower
Extremity Pack, In House Ocular Pack and Closure Kit Containing
Sterile Water Based Products Under Recall by Nurse Assist
Class
I Recall: Abbott Recalls HeartMate Touch Communication System for
Unintentional Pump Start and Stop
|
| March 8, 2024
CDRH's
Experiential Learning Program (ELP) (Updated)
MDUFA
Reports (Updated)
- March 8, 2024, MDUFA V Performance Report
|
|
March 7, 2024
Updated Emergency Use Authorization
- The
AscencioDx COVID-19 Test and The AscencioDx Molecular Detector (ADL
Diagnostics, Inc., dba Anavasi Diagnostics)
MedSun
Newsletter - March 2024
Class
I Recall: Medtronic Neurosurgery Recalls Duet External Drainage
and Monitoring System Catheter Tubing due to a Potential for the
Catheter Disconnection from the Patient Line Stopcock Connectors
Class
I Recall: Ventec Life Systems Recalls VOCSN Patient Breathing Package
(Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded
Spiral Wrap
Class
I Recall: Cardinal Health Recalls Sterile Monoject Luer-Lock and
Enteral Syringes Due to a Change in Manufacturing (Updated)
CDRH
Learn (Updated)
- Presentation and Transcript for Medical Device Sterilization Town
Hall: FDA’s Modifications Guidances and the Use of Device Master
Files in Reviews - February 29, 2024
|
|
March 6, 2024
Dispositivos
médicos de realidad aumentada y realidad virtual: preguntas
que debe considerar
Augmented
Reality and Virtual Reality Medical Devices: Questions to Consider
(Updated)
Class
I Recall: Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400
Due to a Software Error
|
|
March 5, 2024
Medical
Device Single Audit Program (MDSAP) (Updated)
Class
I Recall: Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe
Pump Due to Issues Associated with Earlier Software Versions
Explore
Life at CDRH (Updated)
|
|
March 4, 2024
Federal
Register Documents (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries - OMNIgeneGUT
DX (DEN200040)
|
|
March 1, 2024
New Emergency Use Authorization
- OSOM
Flu SARS-CoV-2 Combo Test (SEKISUI Diagnostics, LLC)
- OSOM
Flu SARS-CoV-2 Combo Home Test (SEKISUI Diagnostics, LLC.)
Class
I Recall: Megadyne Medical Products, Inc. Recalls Mega Soft Universal
Patient Return Electrode Due to Reports of Patient Burns (Updated)
Class
I Recall: Datex-Ohmeda Recalls EVair Air Compressors Due to Formaldehyde
Emissions Found in Specific Conditions When Used with CARESCAPE
R860, Engstrom Carestation or Pro Ventilators
MQSA
National Statistics (Updated)
|
| February 29, 2024
Follow
Instructions for Safe Use of Electrical Operating Room Tables -
Letter to Health Care Providers
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
Transcript:
February 6, 2024 General Hospital and Personal Use Devices Panel
of the Medical Devices Advisory Committee Meeting
Class
I Recall: Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care
Plus models 1000-4000 and Lullaby Incubators Due to Problems with
Door Latch
Hintermann
Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk
of Device Failure: FDA Safety Communication
Federal
Register: Food and Drug Administration Modernization Act: List of
Recognized Standards, Recognition List Number: 061
|
|
February 28, 2024
Virtual
Public Workshop – Accreditation Scheme for Conformity Assessment
Expansion - April 17, 2024
Class
I Recall: Olympus Corporation of the Americas Recalls Bronchofiberscopes
and Bronchovideoscopes Because They Can Lead to Burns and Fire (Updated)
CDRH
Statement: CDRH’s Continued Commitment to Breast Implant Safety
Transcript
and Summary Minutes for February 2, 2024 Anesthesiology and Respiratory
Therapy Devices Panel of the Medical Devices Advisory Committee
Meeting
Federal
Register: Medical Device User Fee Cover Sheet and Device Facility
User Fee Cover Sheet
|
|
February 27, 2024
BioZorb
Markers and Potential Risks with Use in Breast Tissue: FDA Safety
Communication
|
|
February 26, 2024
Updated Emergency Use Authorization
- Abbott
RealTime Zika (Abbott Molecular Inc.)
Medical
Device Sterilization Town Hall: FDA’s Modifications Guidances
and the Use of Device Master Files in Reviews
|
| February 23, 2024
Revoked Emergency Use Authorizations
- xMAP
SARS-CoV-2 Multi-Antigen IgG Assay (Luminex Corporation)
|
|
February 22, 2024
Diagnostic
Data Program (Updated)
Systemic
Harmonization and Interoperability Enhancement for Laboratory Data
(SHIELD) (Updated)
Digital
Diagnostics: Over-the-Counter (OTC) and Point-of-Care (POC) (Updated)
|
|
February 21, 2024
Select
Updates for the Medical Device User Fee Small Business Qualification
and Certification Guidance - Guidance for Industry and Food and
Drug Administration Staff
Reduced
Medical Device User Fees: Small Business Determination (SBD) Program
(Updated)
Update:
Recommendations for Certain Medtronic Electromyogram Endotracheal
Tubes and Risk of Airway Obstruction - Letter to Health Care Providers
(Updated)
Do
Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels:
FDA Safety Communication
Federal
Register: List of Standing Committees: Digital Health Advisory Committee
Federal
Register: Select Updates for the Medical Device User Fee Small Business
Qualification and Certification Guidance; Agency Information Collection
Activities
|
|
February 20, 2024
Fraudulent
and Unreliable Laboratory Testing Data in Premarket Submissions:
FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated
Data
|
| February 15, 2024
Class
I Recall: Philips Recalls BrightView Imaging Systems Due to the
Detector Unexpectedly Falling
|
|
February 14, 2024
Class
I Recall: Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe
Pump Due to Issues Associated with Earlier Software Versions
|
|
February 13, 2024
Presentations
for February 2, 2024 Anesthesiology and Respiratory Therapy Devices
Panel of the Medical Devices Advisory Committee Meeting
|
| February 9, 2024
Materials
for February 13, 2024 Circulatory System Devices Panel of the Medical
Devices Advisory Committee Meeting
Presentations
for February 6, 2024 General Hospital and Personal Use Devices Panel
of the Medical Devices Advisory Committee Meeting
MedSun
Newsletter - February 2024
|
|
February 8, 2024
Current
Career Opportunities at CDRH
24
Hour Summary for February 2, 2024 Anesthesiology and Respiratory
Therapy Devices Panel of the Medical Devices Advisory Committee
Meeting
24
Hour Summary for February 6, 2024 General Hospital and Personal
Use Devices Panel of the Medical Devices Advisory Committee Meeting
|
|
February 7, 2024
International
Medical Device Regulators Forum (IMDRF) (Updated)
CDRH
International Affairs (Updated)
Consumer Information: Edwards
EVOQUE Tricuspid Valve Replacement System - P230013
(Edwards Lifesciences, LLC)
|
|
February 6, 2024
Updated Emergency Use Authorization
- The
AscencioDx COVID-19 Test and The AscencioDx Molecular Detector (ADL
Diagnostics, Inc.)
- iHealth
COVID-19 Antigen Rapid Test Pro (iHealth Labs, Inc.)
At-Home OTC COVID-19 Diagnostic Tests (Updated)
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
- Extended Expiration Date
Meeting
Notice: March 21, 2024 Ophthalmic Devices Panel of the Medical Devices
Advisory Committee
Recall
of Certain Saline and Sterile Water Medical Products Associated
with Nurse Assist: FDA Safety Communication (Updated)
Class
I Recall: Percussionaire Recalls High Frequency Transport Phasitron
Breathing Circuit Kits for Over-Pressurization
|
|
February 5, 2024
CDRH Learn (Updated)
- Presentation
and Transcript for Medical Device Sterilization Town Hall: FDA Activities
and Challenges in Reducing Reliance on Ethylene Oxide (EtO) - January
26, 2024
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
Federal
Register: Hearings, Meetings, Proceedings, etc.: Ophthalmic Devices
Panel of the Medical Devices Advisory Committee, FSYX Ocular Pressure
Adjusting Pump System
|
|
February 2, 2024
Do
Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes
- FDA Safety Communication
At-Home
OTC COVID-19 Diagnostic Tests (Updated Xiamen Boson Biotech Co.,
Ltd. Rapid SARS-CoV-2 Antigen Test Card)
Materials
for February 6, 2024 General Hospital and Personal Use Devices Panel
of the Medical Devices Advisory Committee Meeting
|
|
February 1, 2024
Re-issued Emergency Use Authorizations
- Respiratory
SARS-CoV-2 RT-PCR Panel 1 (Revvity, Inc.)
- New
Coronavirus Nucleic Acid Detection Kit (Revvity, Inc.)
CDRH's
Experiential Learning Program (ELP) (Updated)
COVID-19 Tests Granted Traditional Marketing Authorization by the
FDA (Updated)
- Biofire®
Spotfire® Respiratory (R) Panel Mini (Biofire Diagnostics, LLC)
MQSA
National Statistics (Updated)
Total
Product Life Cycle Advisory Program (TAP) (Updated)
Medical
Device Shortages List (Updated)
Medical
Device Sterilization Town Hall: Discussion of Premarket Submission
Expectations and Additional Considerations for Sterility Review
- February 7, 2024
Federal
Register: Medical Devices; Quality System Regulation Amendments
|
|
|
