|
|
| Endotracheal
Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal
Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation
03/25/2025 |
| Infusion
Pump Software Correction: Becton, Dickinson and Company (BD) Issues
Correction for BD Alaris Systems Manager and Care Coordination Engine
Infusion Adapter Software Due to Risk for Outdated Automated Programming
Requests to Load 03/20/2025 |
| Early
Alert: Aspiration System Issue from Calyxo 03/20/2025 |
| Implantable
Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports
Due to Manufacturing Error that May Cause Separation 03/19/2025 |
| Embolization
Device Recall and Correction: Medtronic Removes Unused 027 Compatible
Pipeline Vantage Embolization Device with Shield Technology, Updates
Use Instructions for 021 Compatible Pipeline Vantage Embolization
Devices due to Increased Risk of Incomplete Wall Apposition and Braid
Deformation 03/18/2025 |
| Early
Alert: Infusion Pump Issue from Baxter Healthcare Corporation
03/05/2025 |
| Endovascular
System Recall: Philips Removes and Discontinues Distribution of Tack
Endovascular System Due to User Challenges That Caused Additional
Procedures to Reposition or Remove Implant 03/03/2025 |
| Vaporizer
Recall: Getinge Removes Vaporizer Sevoflurane Quick-Fil and Expands
Recall of Vaporizer Sevoflurane Maquet Filling due to Risk of Patient
and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride
03/03/2025 |
| Ablation
Catheter Correction: Biosense Webster Updates Use Instructions for
Varipulse due to High Rate of Stroke or Transient Ischemic Attack
02/28/2025 |
| Patient
Table Correction: Philips Updates Use Instructions for Allura and
Azurion Systems due to Patient Fall Risk from Incorrectly Positioned
Mattresses 02/28/2025 |
| Power
Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial
Component Used with SmartDrive MX2+ Power Assist Device Due to Risk
for Motor to Be Unresponsive to the User 02/28/2025 |
| Regard
Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due
to a Recalled Component, the Neo-Tee T-Piece Resuscitator With An
Undersized Controller Spring 02/28/2025 |
| Endoscope
Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due
to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures
02/28/2025 |
| Pacemaker
Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices
Due to a Manufacturing Issue That May Lead to Early Device Replacement
02/21/2025 |
| Heart
Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP
with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk
That the Tip of Guidewires or Other Medical Devices May Come into
Contact with The Impella Pump During Insertion, Adjustment, Or Removal
02/14/2025 |
| Breathing
Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing
Circuits due to Venturi Component Malfunctions that May Reduce Pressure
and Volume Flow 02/10/2025 |
| Arterial
Catheter Recall: Medline Industries, LP, Removes Integrated Arterial
Catheters due to Excess Material at Catheter Hub that May Detach
02/06/2025 |
| Early
Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular
02/06/2025 |
| Oxygen
Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices
spontaneously catching fire 02/05/2025 |
| Continuous
Ventilator Correction: Baxter Healthcare Corporation Issues Correction
for Life2000 Ventilator due to a nonconforming battery charger, which
triggers a battery alarm and renders the ventilator inoperable
02/05/2025 |
| Pressure
Monitoring Device Recall: Medtronic Neurosurgery Issues Correction
for Becker and Exacta External Drainage and Monitoring Systems Due
to Cracks And/Or Leaks in Stopcocks 02/03/2025 |
| Gas
Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee
T-Piece Resuscitator Due to An Undersized Spring in The Controller
That May Prevent the Device from Delivering the Required Pressure
Levels Needed for Effective Ventilation 01/31/2025 |
| Glucose
and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues
Software Correction for StatStrip Glucose and Glucose/Ketone Hospital
Meters Due to Risk for Transmission of Incorrect Patient Results
01/30/2025 |
| Early
Alert: Infusion Pump Software Issue from Fresenius Kabi USA 01/16/2025 |
| Endoscopic
Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular
Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001)
EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone
Peeling or Detaching During Use 01/15/2025 |
| Outpatient
Telemetry Correction: Philips Issues Correction for Monitoring Service
Application used with Mobile Cardiac Outpatient Telemetry Due to Potential
for Missed Information or Notifications That May Impact Patient Care
01/13/2025 |
| Early
Alert: Solution Set Issue from Baxter Healthcare Corporation 12/31/2024 |
| Early
Alert: Fluid Delivery Set Issue from Medline 12/30/2024 |
| Early
Alert: Extracorporeal Blood Circuit Issue from Nuwellis 12/30/2024 |
| Early
Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
12/23/2024 |
| Early
Alert: Nephroscope Sheath Issue from Trokamed GmbH 12/20/2024 |
| Catheter
Correction: Boston Scientific Updates Use Instructions for POLARx
and POLARx FIT Cryoablation Balloon Catheters due to Higher than Anticipated
Number of Reports of Atrio-Esophageal Fistula 12/18/2024 |
| Implantable
Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers due
to Risk for Patient Complications 12/18/2024 |
| Early
Alert: Infusion Pump Issue from Fresenius Kabi USA 12/11/2024 |
| Neonatal
Incubator Correction: GE HealthCare Updates Use Instructions for GE
HealthCare Giraffe OmniBed Carestation and Incubator Carestation due
to Risk of Patient Formaldehyde Exposure 12/06/2024 |
| Syringe
Recall: Cardinal Health Removes Certain Monoject U-100 mL Insulin
Syringe Luer Lock with Tip Cap Soft Packs due to Incompatibility with
Needleless Connectors 12/04/2024 |
| Hemodialysis
Correction: Baxter Issues Correction for AK 98 Hemodialysis Machines
Due to Risk of Patient Exposure to Higher Than Allowable Levels of
Toxic Compound NDL-PCBA and/or NDL-PCBs 11/29/2024 |
| Peritoneal
Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended
Life Peritoneal Dialysis Transfer Sets Due to Risk of Patient Exposure
to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or
NDL-PCBs 11/29/2024 |
| Insertion
Tube Recall: FHC Removes microTargeting Insertion Tube Sets due to
a Manufacturing Size Error That May Lead to Patient Harm 11/29/2024 |
| Biopsy
Needle Recall: Elekta Removes Disposable Biopsy Needle Kits due to
Risk of Microscopic Stainless Steel Debris Inside Needle 11/29/2024 |
| Anesthesia
Machine Correction: Draeger, Inc., Issues Correction for Atlan A350
and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation
Failure 11/19/2024 |
| Endoscopic
Vessel Harvesting System Recall: Getinge and Maquet Cardiovascular
Remove VasoView HemoPro 1 and 1.5 Endoscopic Vessel 11/15/2024 |
| IPV
Therapy Device Recall: Percussionaire Removes Certain Phasitron 5
Breathing Circuits Due to Risk of Nickel Exposure 11/01/2024 |
| Incubator/Warmer
Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed
and Giraffe Omnibed CareStation due to Risk of Heater Door Falling
and Causing Infant Injury 10/31/2024 |
| Assistive
Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic
Arm due to Fire Hazard and Burn Risk 10/25/2024 |
| Tracheostomy
Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc
Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon
10/25/2024 |
| Insulin
Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series
Pumps of Risk of Shorter than Expected Battery Life 10/17/2024 |
| Infusion
Pump Recall: Zyno Medical Removes Z-800, Z-800F, Z-800W, and Z800WF
Infusion Pumps due to an Air-in-Line Software Defect That May Allow
Larger than Expected Air Bubbles to Enter Patients 10/11/2024 |
| Resuscitator
Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due
to Risk of Inline Controller Detachment that May Impact Ventilation
10/07/2024 |
| IPV
Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions
for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory
Port Plug 10/02/2024 |
| Ventilator
Software Correction: Philips Respironics Issues Mandatory Software
Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2,
and Evo Universal to Address Multiple Issues that May Impact Ventilation
10/01/2024 |
| Infusion
Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction
for Ivenix Infusion System Large Volume Pump (LVP) Software due to
Multiple Anomalies that May Cause Delay or Underdosage of Therapy
10/01/2024 |
| Ventilator
Correction: Smiths Medical Issues Correction for paraPAC Plus P300
and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement
09/30/2024 |
| Compounding
Device Inlet Correction: Baxter Healthcare Corporation Updates Use
Instructions for Exactamix Automated Compounding Device Inlets due
to Risk for Particulate Matter in Device Components 09/24/2024 |
| Ventilator
Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened
or Detached Patient Outlet Connector 09/20/2024 |
| Tracheostomy
Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric
and Adult Tracheostomy Tubes due to Manufacturing Defect that May
Cause Tracheostomy Displacement or Decannulation 09/18/2024 |
| Infusion
Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat
Space Infusion System/Large Volume Pump, in addition to Infusomat
Space Large Volume Pump Wireless, and lnfusomat Space Large Volume
Pump Non-Wireless BATTERY PACK, Due to Faulty Occlusion Alarm
09/17/2024 |
| Infusion
Pump Administration Set Recall: Fresenius Kabi USA Removes Certain
Ivenix Large Volume Pump Primary Administration Sets 09/16/2024 |
| Continuous
Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc Issues
Recall for Certain FreeStyle Libre 3 Sensors due to Risk for Inaccurate
High Glucose Readings 09/05/2024 |
| Ventilator
Correction: Breas Medical Updates Use Instructions for Vivo 45 LS
due to Potential Elevated Formaldehyde Levels in Newly Manufactured
Ventilators 09/05/2024 |
| Laryngoscope
Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes,
Updates Use Instructions for Others due to Increased Risk for Battery
Overheat and Explosion 09/05/2024 |
| Lung
Therapy Component Recall: Baxter Healthcare Corporation Recalls Certain
Volara System Single-Patient Use Circuits and Blue Ventilator Adapter
Assemblies Due to Disconnection Risk That May Prevent Proper Ventilation
09/04/2024 |
| Clot
Removal Device Correction: Inari Medical Updates Use Instructions
for ClotTriever XL Catheter due to Reports of Patient Injury and Death
from Device Entrapment and Pulmonary Emboli 08/23/2024 |
| Convenience
Kit Component Recall: Medline Industries, LP, Removes Convenience
Kit Syringes Manufactured in China that May Be Contaminated, Break,
Leak, or Otherwise Fail 08/23/2024 |
| Chest
Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR
Chest Compression Device due to Risk of Device Stopping Compressions
08/22/2024 |
| Infusion
Pump Battery Correction: ICU Medical Updates Instructions for Use
Regarding Batteries in Plum 360, A+ and A+3 Infusion System due to
Diminished Battery Life that May Impact Infusion Delivery 08/20/2024 |
| Heart
Pump Recall: Abiomed Removes Certain Impella CP with SmartAssist Systems
due to Failed Quality Inspections 08/12/2024 |
| Nerve
Monitoring System Correction: Medtronic Issues Correction for NIM
Vital Nerve Monitoring System due to the Potential for False Negative
Response 08/06/2024 |
| Ambulatory
Infusion Pump Software Correction: Smiths Medical Issues Correction
for CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pump Software
due to Multiple Issues Related to Outdated Software 08/06/2024 |
| Eye
Injection Kit Recall: Bausch + Lomb/Synergetics Inc. Removes Certain
I-Pack Injection Kits Due to Potential Non-Sterility 07/15/2024 |
| Ventilator
Recall: Baxter Removes Life2000 Ventilator Due to Potential Failure
of Battery Charging Dongle 07/15/2024 |
| Electrode
Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT
DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric
Burns 07/11/2024 |
| Ventilator
Software Correction: Hamilton Medical Issues Correction for HAMILTON-C6
Medical Ventilators to Address Risk of Failed Ventilation Restart
07/11/2024 |
| An
Implantable Hypoglossal Nerve Stimulator Device Removal: Inspire Medical
Systems, Inc. Removes Inspire IV Implantable Pulse Generator due to
Manufacturing Defect That Can Result in System Malfunctions 07/08/2024 |
| Radiofrequency
(RF) Coils Correction: Philips North America LLC Updates Use Instructions
For SENSE XL Torso (1.5T And 3.0T) Coils Due to a Potential Issue
Where the Coil Heats Up During MRI Scans, Possibly Leading to Thermal
Injury 07/08/2024 |
For the most up to date FDA headlines, see the FDA
Medical Device News page.
| January 17, 2025
Revised Emergency Use Authorization
- Flowflex
Plus COVID-19 and Flu A/B Home Test (ACON Laboratories, Inc.)
At-Home OTC COVID-19 Diagnostic Tests
- Flowflex
Plus COVID-19 and Flu A/B Home Test (ACON Laboratories, Inc.) -
Extended Expiration Date
CDRH
2024 Annual Report
MedSun
Newsletter - January 2025
|
|
January 16, 2025
CDRH
Statement: Medical Device Supply Chain Vulnerabilities and the Public
Health Impact They Have on Our Most Vulnerable Patients
Update:
Evaluation of Airborne Chemicals from Neonatal Incubators - Letter
to Health Care Providers
Early
Alert: Infusion Pump Software Issue from Fresenius Kabi USA
|
|
January 15, 2025
Definitions
and General Oversight: Laboratory Developed Tests FAQs (Updated)
Phaseout
Policy and Enforcement Discretion Policies: Laboratory Developed
Tests FAQs (Updated)
Medical
Device Reporting, Complaints, and Corrections & Removals Reporting:
Laboratory Developed Tests FAQs (Updated)
Class
I Recall: Endoscopic Vessel Harvesting (EVH) System Correction:
Getinge and Maquet Cardiovascular Update Use Instructions for VasoView
HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent
or Detached Heater Wires and Silicone Peeling or Detaching During
Use
Total
Product Life Cycle Advisory Program (TAP) (Updated)
Accreditation
Scheme for Conformity Assessment (ASCA) (Updated)
- ASCA
2024 Annual Report
|
|
January 14, 2025
Recognized
Consensus Standards Database (Updated)
|
|
January 13, 2025
Revoked
Emergency Use Authorizations
- Access SARS-CoV-2 IgG (Beckman Coulter, Inc.)
- Access SARS-CoV-2 IgM (Beckman Coulter, Inc.)
- Access SARS-CoV-2 IgG II (Beckman Coulter, Inc.)
De Novo Decision Summary:
- DEN230027
- NaviCam ProScan
Premarket
Approval Application and Humanitarian Device Exemption Modular Review
- Guidance for Industry and FDA Staff
Class
I Recall: Outpatient Telemetry Correction: Philips Issues Correction
for Monitoring Service Application used with Mobile Cardiac Outpatient
Telemetry Due to Potential for Missed Information or Notifications
That May Impact Patient Care
Recalls,
Corrections and Removals (Devices) (Updated)
|
| January 8, 2025
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA - Molecular
Diagnostic Tests (Updated)
- DASH SARS-CoV-2 & Flu A/B Test (Nuclein, LLC)
Getting
a Radiation Emitting Product to Market: Frequently Asked Questions
(Updated)
Webinar:
Investigational Use Requirements for In Vitro Diagnostic Products
(IVDs), including Laboratory Developed Tests (LDTs) Under 21 CFR
812 - February 25, 2025
Laboratory
Developed Tests (Updated)
Consumer Information: PyloPlus
UBT System - P170022/S003
(ARJ Medical Inc.)
Federal
Register: Requests for Nominations: Technical Electronic Product
Radiation Safety Standards Committee
|
|
January 7, 2025
Consumer Information: Oncomine
Dx Target Test - P160045/S046
(Life Technologies Corporation)
|
|
January 6, 2025
Pulse
Oximeters for Medical Purposes - Non-Clinical and Clinical Performance
Testing, Labeling, and Premarket Submission Recommendations - Draft
Guidance for Industry and Food and Drug Administration Staff
Pulse
Oximeters (Updated)
Validation
of Certain In Vitro Diagnostic Devices for Emerging Pathogens During
a Section 564 Declared Emergency - Draft Guidance for Industry and
Food and Drug Administration Staff
Artificial
Intelligence-Enabled Device Software Functions: Lifecycle Management
and Marketing Submission Recommendations - Draft Guidance for Industry
and Food and Drug Administration Staff
Evaluation
of Sex-Specific and Gender-Specific Data in Medical Device Clinical
Studies - Draft Guidance for Industry and Food and Drug Administration
Staff
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
Medical
Device Supply Chain and Shortages (Updated)
Supply
and Shortages of Medical Devices: Frequently Asked Questions (Updated)
506J
Device List (Updated)
Webinar
- Final Guidance: Notifying FDA of a Permanent Discontinuance or
Interruption in Manufacturing of a Device Under Section 506J of
the FD&C Act - March 4, 2025
Federal
Register: Artificial Intelligence-Enabled Device Software Functions:
Lifecycle Management and Marketing Submission Recommendations; Draft
Guidance for Industry and Food and Drug Administration Staff
Federal
Register: Validation of Certain In Vitro Diagnostic Devices for
Emerging Pathogens During a Section 564 Declared Emergency; Draft
Guidance for Industry and Food and Drug Administration Staff
Federal
Register: Pulse Oximeters for Medical Purposes - Non-Clinical and
Clinical Performance Testing, Labeling, and Premarket Submission
Recommendations; Draft Guidance for Industry and Food and Drug Administration
Staff
Federal
Register: Notifying the Food and Drug Administration of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the Federal Food, Drug, and Cosmetic Act; Guidance
for Industry and Food and Drug Administration Staff
Federal
Register: Evaluation of Sex-Specific and Gender-Specific Data in
Medical Device Clinical Studies; Draft Guidance for Industry and
Food and Drug Administration Staff
|
| January 3, 2025
Federal
Register: Requests for Nominations: National Mammography Quality
Assurance Advisory Committee
|
| January 2, 2025
Total
Product Life Cycle Advisory Program (TAP) (Updated)
MQSA
National Statistics (Updated)
|
| December 31, 2024
Early
Alert: Solution Set Issue from Baxter Healthcare Corporation
|
|
December 30, 2024
February
20, 2025: General and Plastic Surgery Devices Panel of the Medical
Devices Advisory Committee Meeting Announcement
Virtual
Public Meeting – Food and Drug Administration, Center for Devices
and Radiological Health Real-World Evidence Update - 01/30/2025
Early
Alert: Extracorporeal Blood Circuit Issue from Nuwellis
Early
Alert: Fluid Delivery Set Issue from Medline
CDRH
Statement: CDRH Unveils Home as a Health Care Hub’s Idea Lab
to Help Reimagine How New and Existing Medical Technologies Can
Be Incorporated Into the Home
Home
as a Health Care Hub (Updated)
- Idea
Lab
- Home
as a Health Care Hub - Understanding the Need
- Frequently
Asked Questions for the Home as a Health Care Hub (Updated)
|
| December 27, 2024
Federal
Register: General and Plastic Surgery Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting; Establishment of
Public Docket; Request for Comments--Dermal Fillers
Federal
Register: Requests for Nominations: Individuals and Consumer Organizations
for Advisory Committees
Federal
Register: Requests for Nominations: Patient Engagement Advisory
Committee
|
|
December 23, 2024
De Novo Reclassification Order(s):
- DEN230027
- NaviCam ProScan
- DEN240014
- ARCEX System
De Novo Decision Summary:
- DEN240014
- ARCEX System
Biocompatibility
and Toxicology Program: Research on Medical Devices, Biocompatibility,
and Toxicology (Updated)
Early
Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from
Olympus
|
| December 20, 2024
Clinical
Decision Support Software Frequently Asked Questions (FAQs)
Artificial
Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
(Updated)
Early
Alert: Nephroscope Sheath Issue from Trokamed GmbH
Class
I Recall: Infusion Pump Battery Recall: ICU Medical Removes Some
CSB Batteries Intended For Use With Plum 360, A+, and A+3 Infusion
Systems Due to Reports of Allegedly Counterfeit, Untested Batteries
In Use
Medical
Device Sterilization Town Hall: Sterilization Short Topics, Series
Impact, Wrap Up, and Next Steps - December 4, 2024
- Presentation
(YouTube)
- Transcript
|
|
December 19, 2024
How
TAP Facilitates Engagement with Non-FDA Parties (Updated)
|
|
December 18, 2024
Class I Recalls:
-
Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable
Markers due to Risk for Patient Complications
- Catheter
Correction: Boston Scientific Updates Use Instructions for POLARx
and POLARx FIT Cryoablation Balloon Catheters due to Higher than
Anticipated Number of Reports of Atrio-Esophageal Fistula
|
|
December 17, 2024
Global
Unique Device Identification Database (GUDID) - Guidance for Industry
and Food and Drug Administration Staff
Global
Unique Device Identification Database (GUDID) (Updated)
Prepare
for GUDID (Updated)
Submit
Data to GUDID (Updated)
Collaborative
Communities: Addressing Health Care Challenges Together - Participating
in Connected Health Collaborative Community (Updated)
|
|
December 16, 2024
De Novo Decision Summaries (Updated):
- DEN210049
- Medline ART Skin Harvesting System
- DEN220091
- Dream Sock
De Novo Reclassification:
- DEN240025
- VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail Assay
Accolade
Pacemaker Devices by Boston Scientific and Potential Need for Early
Device Replacement - FDA Safety Communication
|
| December 11, 2024
Consumer Information: nAbCyte
Anti-AAVRh74var HB-FE Assay - H230005
(LabCorp Drug Development)
Early
Alert: Infusion Pump Issue from Fresenius Kabi USA
2024
Medical Device Recalls (Updated)
Federal
Register: Emergency Use Authorization: B. Braun Medical's Perfusor
Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion
Pump System, and Outlook ES; Revocation
|
|
December 10, 2024
De Novo Decision Summaries (Updated):
- DEN220047
- Galen ES Cooperative Surgical Assistant Platform, Galen ES
- DEN220052
- BrachyGel Vaginal Hydrogel Packing System
MedSun
Newsletter - December 2024
|
|
December 9, 2024
Safety
and Availability Concerns with VasoView HemoPro Endoscopic Vessel
Harvesting Systems - Letter to Health Care Providers (Updated)
OSEL
Summer Research Program (Updated: 2025 Summer Program now open)
|
| December 6, 2024
Class
I Recall: Neonatal Incubator Correction: GE HealthCare Updates Use
Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator
Carestation due to Risk of Patient Formaldehyde Exposure
CDRH
Learn: Presentation and Transcript posted for Registration &
Listing Requirements for In Vitro Diagnostic Products (IVDs), Including
Laboratory Developed Tests (LDTs) Webinar - December, 3, 2024
|
|
December 5, 2024
Reports
on Non-Device Software Functions
- 2024
Report on Non-Device Software Functions (PDF - 1.72 MB)
Revised Emergency Use Authorizations
- Quest
Diagnostics Mpox Virus Qualitative Real-Time PCR (2-well) (Quest
Diagnostics Nichols Institute)
|
|
December 4, 2024
Class
I Recall: Syringe Recall: Cardinal Health Removes Certain Monoject
U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs due to
Incompatibility with Needleless Connectors
Medical
Device Shortages List (Updated)
Consumer
Information: Esprit BTK Everolimus Eluting Resorbable Scaffold System
- P230036 (Abbott Medical)
|
|
December 3, 2024
De Novo Decision Summaries (Updated):
- DEN230061
- Allay Nerve Cap
- DEN230078
- Versius Surgical System
- DEN230068
- 3MTM ATTESTTM EBowie-Dick Test
- DEN230076
- Omron Blood Pressure Monitor with AFIB Detection Feature
- DEN220042
- Terragene Bionova Photon Biological Indicator & Auto Reader
Incubator (BPH)
De Novo Classification Order:
- DEN230085
- VERIFYTM RESI-TESTTM SLIDE-THRU Cleaning
Process Protein (CPP) Indicator
- DEN240023
- SmartFlow Neuro Cannula
Marketing
Submission Recommendations for a Predetermined Change Control Plan
for Artificial Intelligence-Enabled Device Software Functions -
Guidance for Industry and Food and Drug Administration Staff
Webinar
– Final Guidance: Marketing Submission Recommendations for
a Predetermined Change Control Plan for Artificial Intelligence-Enabled
Device Software Functions
Predetermined
Change Control Plans for Machine Learning-Enabled Medical Devices:
Guiding Principles (Updated)
Artificial
Intelligence and Machine Learning in Software as a Medical Device
(Updated)
Guidances
with Digital Health Content (Updated)
Medical
Device Single Audit Program (MDSAP) (Updated)
Consumer Information: Lumicelli
Direct Visualization System - P230014
(Lumicell, Inc.)
Medical
Device Sterilization Town Hall: Sterilization Short Topics, Series
Impact, Wrap Up, and Next Steps - December 4, 2024
- Printable
Slides
Federal
Register: Guidance: Marketing Submission Recommendations for a Predetermined
Change Control Plan for Artificial Intelligence-Enabled Device Software
Functions
|
|
December 2, 2024
GUDID
Data Trends (Updated)
|
| November 29, 2024
Class I Recalls
- Biopsy
Needle Recall: Elekta Removes Disposable Biopsy Needle Kits due
to Risk of Microscopic Stainless Steel Debris Inside Needle
- Insertion
Tube Recall: FHC Removes microTargeting Insertion Tube Sets due
to a Manufacturing Size Error That May Lead to Patient Harm
- Hemodialysis
Correction: Baxter Issues Correction for AK 98 Hemodialysis Machines
Due to Risk of Patient Exposure to Higher Than Allowable Levels
of Toxic Compound NDL-PCBA and/or NDL-PCBs
- Peritoneal
Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended
Life Peritoneal Dialysis Transfer Sets Due to Risk of Patient Exposure
to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or
NDL-PCBs
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Administrative Detention and Banned Medical Devices
|
|
November 26, 2024
Medical
Device Sterilization Town Hall: Sterilization Short Topics, Series
Impact, Wrap Up, and Next Steps, December 4, 2024
Sterilization
for Medical Devices (Updated)
|
|
November 25, 2024
Transitional
Enforcement Policy for Ethylene Oxide Sterilization Facility Changes
for Class III Devices - Guidance for Industry and Food and Drug
Administration Staff
November
22, 2024 MDUFA V Performance Report
Total
Product Life Cycle Advisory Program (TAP) (Updated)
Federal
Register: Guidance: Transitional Enforcement Policy for Ethylene
Oxide Sterilization Facility Changes for Class III Devices
|
| November 22. 2024
CDRH
Petitions (Updated)
|
|
November 21, 2024
Standards
Newsletter from the Division of Standards and Conformity AssessmentExternal
Link Disclaimer
Orthopedic
Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification
(510(k)) Submissions - Guidance for Industry and Food and Drug Administration
Staff
Orthopedic
Non-Spinal Metallic Bone Screws and Washers - Performance Criteria
for Safety and Performance Based Pathway - Guidance for Industry
and Food and Drug Administration Staff
CDRH
Announces Communications Pilot to Enhance Medical Device Recall
Program
Federal
Register: Guidance: Orthopedic Non-Spinal Bone Plates, Screws, and
Washers--Premarket Notification (510(k)) Submissions
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November 20, 2024
510(k)
Third Party Review Program and Third Party Emergency Use Authorization
(EUA) Review - Guidance for Industry, Food and Drug Administration
Staff, and Third Party Review Organizations
Federal
Register: Guidance: 510(k) Third Party Review Program and Third
Party Emergency Use Authorization Review
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November 19, 2024
Class I Recall:
- Battery
Pack Correction: Smiths Medical Updates Use Instructions for CADD-Solis
Li-ion Rechargeable Battery Packs Due to Risk That Pack Damage May
Cause a Circuit Short and Prevent Recharge
- Ventilator
Correction: Philips Updates Use Instructions for Trilogy Evo, EvoO2,
EV300, Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2,
due to Risk of Inaccurate Flow Measurements Caused by Certain In-Line
Nebulizer Placements
- Anesthesia
Machine Correction: Draeger, Inc., Issues Correction for Atlan A350
and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation
Failure
Medical
Device Development Tools (MDDT) - Summary of Evidence and Basis
of Qualification For WOUND-Q
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A - November 20, 2024
- Printable
Slides
Revised Emergency Use Authorizations
- NxTAG
Respiratory Pathogen Panel + SARS-CoV-2 03/03/2021 (Luminex
Molecular Diagnostics, Inc.)
- Nano-Check
Influenza+COVID-19 Dual Test (Nano-Ditech Corporation)
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
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|
November 18, 2024
Agenda
and Roster for November 20-21, 2024 Digital Health Advisory Committee
Meeting
De Novo Decision Summaries (Updated):
- DEN230052
- Eversense AP CGM System
- DEN240029
- Healgen Rapid Check COVID-19/Flu A & B Antigen Test
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Revised Emergency Use Authorizations
- ViraDx
SARS-CoV-2/Flu A+B Rapid Antigen Test (Princeton BioMeditech
Corp.)
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| November 15, 2024
Consumer Information: GORE
EXCLUDER Conformable AAA Endoprostheses (EXCC) - P200030/S014
(W.L. Gore & Associates, Inc.)
Consumer Information: TruSight
Oncology Comprehensive - P230011
(Illumina, Inc)
Consumer Information: Simplera
system - P160007/S047
(Medtronic MiniMed, Inc.)
Consumer
Information: UNIPURE SF6 Ophthalmic Gas UNIFEYE Gas Delivery System
and UNIPURE SF6 Ophthalmic Gas UNIPEXY Gas Delivery System -
P230012
(Alcon Research, LLC)
Class
I Recall: Endoscopic Vessel Harvesting System Recall: Getinge and
Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic
Vessel
Safety
and Availability Concerns with VasoView HemoPro Endoscopic Vessel
Harvesting Systems - Letter to Health Care Providers
Medical
Device Shortages List (Updated)
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A - November 20, 2024
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
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|
November 14, 2024
Blood
Glucose Monitoring Devices (Updated)
De Novo Decision Summaries (Updated):
- DEN230092
- Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack
& Sample Prep Kit
- DEN230011
- OcuCool
- DEN240016
- Xpert HCV; GeneXpert Xpress System
- DEN220030
- RemeOs™ Screw LAG Solid
- DEN240007
- BioHealx Anal Fistula Device
De Novo Classification Order:
- DEN230082
- Stone Clear
- DEN230083
- Valeda Light Delivery System
- DEN230084
- Dexter L6 Surgical System
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November 12, 2024
Updated Emergency Use Authorization
- ORAcollect·RNA
OR-100 and ORAcollect·RNA ORE-100 saliva collection devices
(DNA Genotek Inc.)
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| November 8, 2024
Reclassification
(Updated)
Evaluation
of Airborne Chemicals from Neonatal Incubators - Letter to Health
Care Providers (Updated)
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|
November 7, 2024
Breakthrough
Devices Program (Updated)
Presentation
and Transcript added to Medical Device Sterilization Town Hall:
Sterilization Short Topics and Open Q&A - October 30, 2024
Alternative
Standards (MQSA): #25: Issuing a Report with the Assessment “Incomplete:
Need additional imaging evaluation” in Follow-Up to an Initial
Report with the Assessment “Incomplete: Need prior mammograms
for comparison.”
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November 6, 2024
Updated Emergency Use Authorization
- cobas
MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (Roche
Molecular Systems, Inc.)
CDRH
– A Great Place for Public Health Service Officers to Work
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November 5, 2024
Materials
for November 7, 2024 General and Plastic Surgery Devices Panel of
the Medical Devices Advisory Committee Meeting
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November 4, 2024
De Novo Decision Summaries (Updated):
- DEN220024
- ScanNav Anatomy Peripheral Nerve Block
- DEN210037
- SoClean 3+ Bacterial Reduction Device
- DEN230046
- PGDx elio™ plasma focus Dx
- DEN230067
- Germitee Chronos®
- DEN230069
- Mi-CHORD System
- DEN230090
- First To Know Syphilis Test
MedSun
Newsletter - November 2024
Explore
Life at CDRH (Updated)
MQSA
National Statistics (Updates)
|
| November 1, 2024
Class
I Recall: IPV Therapy Device Recall: Percussionaire Removes Certain
Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure
|
| October 31, 2024
Class
I Recall: Incubator/Warmer Correction: GE Healthcare Updates Use
Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation
due to Risk of Heater Door Falling and Causing Infant Injury
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|
October 29, 2024
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Webinar
– FDA’s Total Product Life Cycle Approach to In Vitro
Diagnostic Products (IVDs), October 24, 2024
- Presentation
- Transcript
Update:
Use of GE HealthCare EVair and EVair 03 Compressors - Letter to
Health Care Providers
Class
I Recall: Air Compressor Device Correction: GE HealthCare Provides
Updates to EVair Compressors Due to Final Formaldehyde Testing Results
CDRH
Learn (Updated Presentations)
- How
to Complete Form FDA 3602: MDUFA Small Business Qualification and
Certification for a Business Headquartered in the United States
- How
to Complete Form FDA 3602A: MDUFA Foreign Small Business Certification
Request for a Business Headquartered Outside the United States
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|
October 28, 2024
Cybersecurity
(Updated)
De Novo Decision Summaries (Updated):
- DEN230023
- Rho
- DEN230034
- X100 with Full Field Bone Marrow Aspirate (BMA) Application, X100HT
with Full Field Bone Marrow Aspirate (BMA) Application
- DEN230045
- Sonu
- DEN230055
- FSYX™ Ocular Pressure Adjusting Pump System
Meeting
materials for October 30, 2024 Patient Engagement Advisory Committee
Meeting
In
Vitro Diagnostics (IVD) Roundtable – Fall Meeting
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A
- Printable
Slides
|
| October 25, 2024
Class I Recall:
- Tracheostomy
Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc
Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon
- Assistive
Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic
Arm due to Fire Hazard and Burn Risk
Update:
Do Not Use BioZorb Marker Implantable Radiographic Marker Devices:
FDA Safety Communication
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|
October 24, 2024
Revised Emergency Use Authorizations
- OHC
COVID-19/Flu Antigen Test Pro - OSANG LLC
- QuickFinder
COVID-19/Flu Antigen Self Test - OSANG LLC
Updated Emergency Use Authorizations
- Lucira
by Pfizer COVID-19 & Flu Test - Pfizer Inc.
- Flowflex
Plus COVID-19 and Flu A/B Home Test - ACON Laboratories, Inc.
Webinar
– FDA’s Total Product Life Cycle Approach to In Vitro
Diagnostic Products (IVDs), October 24, 2024
- Printable
Slides
Class
I Recall: Ventilator Correction: Baxter Healthcare Updates Use Instructions
for Life2000 Ventilation System Due to Risk of No Low Gas Pressure
Alarm
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|
October 23, 2024
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A - October 30, 2024
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|
October 22, 2024
IDE
Application (Updated)
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|
October 21, 2024
De Novo Classification Order:
- DEN230076
- Omron Blood Pressure Monitor with AFib Detection Feature
- DEN230078
- Versius Surgical System
- DEN230087
- AMStent® Tracheobronichial Covered Stent System
DeNovo Decision Summaries (Updated):
- DEN220009
- VerTouch Spinal Imaging Device
- DEN220066
- BrainSee
- DEN230006
- esolution® Esophageal Retractor
- DEN230011
- OcuCool
- DEN230032
- Symani Surgical System
- DEN230064
- BraidE Embolization Assist Device
- DEN240017
- ShortCut
Reclassification
(Updated)
Federal
Register: Chemical Analysis for Biocompatibility Assessment of Medical
Devices
|
| October 18, 2024
Total
Product Life Cycle Advisory Program (TAP) (Updated)
Class
I Recall: Vascular Embolization Device Correction: Boston Scientific
Updates Use Instructions for Obsidio Conformable Embolic for Increased
Ischemia Risk When Used for GI Bleeding
Webinar
- Draft Guidance: Incorporating Voluntary Patient Preference Information
over the Total Product Life Cycle - 10/15/2024 (Updated)
- Presentation
-
Printable Slides
- Transcript
|
|
October 17, 2024
Class
I Recall: Insulin Pump Recall: Medtronic Notifies Users of MiniMed
600 and 700 Series Pumps of Risk of Shorter than Expected Battery
Life
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A
- Presentation
- Printable
Slides
- Transcript
Federal
Register: Accreditation Scheme for Conformity Assessment Program
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|
October 16, 2024
Ventilators
and Ventilator Accessories EUAs (Updated)
CDRH
Petitions (Updated)
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|
October 15, 2024
Influenza
Diagnostic Tests (Updated)
Electronic
Medical Devices, X-ray Imaging and Radiation Therapy: What to Know
and How to Prevent Damage
Device
Trial Participation Snapshots
De Novo Classification Order: DEN240029
- Healgen Rapid Check COVID-19/flu A&B Antigen Test
De Novo Decision Summaries (Updated):
- DEN200076
- ORi
- DEN210058
- ELEOSx™ Limb Salvage System
- DEN220015
- Orthobond Mariner Pedicle Screw System
- DEN220073
- Revi System
- DEN230008
- DermaSensor
- DEN230035
- DentalMonitoring
- DEN230043
- Notal Vision Home Optical Coherence Tomography (OCT) System
- DEN230081
- Hearing Aid Feature
- DEN240013
- MagDI System
|
| October 11, 2024
Revoked Emergency Use Authorizations
- Cue
COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health
Inc.)
- Cue
COVID-19 Test (Cue Health Inc.)
Endosseous
Dental Implants and Endosseous Dental Implant Abutments - Performance
Criteria for Safety and Performance Based Pathway - Guidance for
Industry and Food and Drug Administration Staff
Safety
and Performance Based Pathway (Updated)
Class
I Recall: Infusion Pump Recall: Zyno Medical Removes Certain Z-800,
Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line
Software Defect That May Allow Larger than Expected Air Bubbles
to Enter Patients
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|
October 10, 2024
CDRH
Proposed Guidance Development (Updated)
CDRH
Proposed Guidances for Fiscal Year 2025 (FY2025)
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October 8, 2024
Consumer Information: SHIELD
- P230009
(Guardant Health, Inc.)
Resources
and Interactions with FDA: Laboratory Developed Tests FAQs (Updated)
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A - October 9, 2024
- Printable
Slides
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|
October 7, 2024
Consumer Information: UNIPURE
C3F8 Ophthalmic Gas, UNIFEYE Gas Delivery System, UNIPLEX Gas Delivery
System - P220030
(Alcon Research, LLC)
Consumer Information: MYNX
Control™ Venous Closure Device (VCD) - P040044/S097
(Cordis US Corporation)
De Novo Decision Summaries (Updated):
- DEN230015
- Osteoboost Belt
- DEN230024
- Technozym ADAMS13 Activity
De Novo Classification Orders:
- DEN230019
- AXIOS Stent and ElectroUcautery-Enhanced Delivery System
- DEN230011
- OcuCool
- DEN240017
- ShortCut
CDRH's
Experiential Learning Program (ELP) (Updated)
Experiential
Learning Program (ELP) Areas of Interest (Updated)
Class
I Recall: Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece
Resuscitators due to Risk of Inline Controller Detachment that May
Impact Ventilation
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|
October 4, 2024
Revoked Emergency Use Authorization
- B.
Braun Space and Outlook Pumps (B.Braun Medical, Inc.)
Total
Product Life Cycle Advisory Program (TAP) (Updated)
|
|
October 3, 2024
Revised Emergency Use Authorizations
- Tyfast
Flu A/B & COVID-19 Multiplex Rapid Test (CorDx, Inc.)
- TyFast
Flu A/B & COVID-19 At Home Multiplex Rapid Test (CorDx, Inc.)
Updated Emergency Use Authorization
- COVID-19/Flu
A&B Ag Combo Rapid Test Cassette (Swab) (Healgen Scientific,
LLC)
Send
and Track Medical Device Premarket Submissions Online: CDRH Portal
(Updated)
CDRH
Learn: MDUFA Small Business Program (Updated)
MedSun
Newsletter - October 2024
|
|
October 2, 2024
MQSA
National Statistics (Updated)
Class
I Recall: IPV Therapy Device Correction: Sentec/Percussionaire Updates
Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental
Misuse of Expiratory Port Plug
Medical
Device Shortages List (Updated)
|
|
October 1, 2024
Class
I Recall: Infusion Pump Software Correction: Fresenius Kabi USA,
LLC, Issues Correction for Ivenix Infusion System Large Volume Pump
(LVP) Software due to Multiple Anomalies that May Cause Delay or
Underdosage of Therapy
Class
I Recall: Ventilator Software Correction: Philips Respironics Issues
Mandatory Software Correction and Updates Use Instructions for Trilogy
Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues
that May Impact Ventilation
Webinar
- Registration & Listing Requirements for In Vitro Diagnostic
Products (IVDs), Including Laboratory Developed Tests (LDTs) - 12/03/2024
Total
Product Life Cycle Advisory Program (TAP) (Updated)
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