|
|
| 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 |
| Continuous
Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions
for OmniLab Advanced+ (OLA+) Ventilator due to Interruptions and/or
Loss of Therapy 06/28/2024 |
| Left
Ventricular Assist System (LVAS) Monitor Correction: Abbott Medical
Issues Correction for HeartMate LVAS System Monitor due to Screen
Issues that May Cause Unintentional Pump Stop 06/28/2024 |
| Ventilator
Correction: ZOLL Medical Corporation Updates Use Instructions For
731 Ventilators Due to Missing MRI Safety Information in The Labeling
That May Lead to Misuse and Ventilator Failure 06/27/2024 |
| Continuous
Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions
for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or Loss
of Therapy 06/27/2024 |
| Electrode
Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient
Return Electrodes for Risk of Serious Burn Injuries to Patients
06/13/2024 |
| Getinge
Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient and
Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride
06/13/2024 |
| Teleflex/Arrow
International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon
(IAB) Catheter Kits for Manufacturing Issue That May Prevent Full
Balloon Inflation and Cause Patient Harm 06/13/2024 |
| Endotracheal
Tube Recall: Medline Industries, LP Removes Medline Sub-G Endotracheal
Tube with Subglottic Suctioning due to Detachment or Tearing of the
Inflation Tube from the Main Tube 06/11/2024 |
| Medtronic
Recalls StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3,
1.0.2, and 1.0.1 for Software Error that May Cause Incorrect Measurements
During Cranial Surgery 06/05/2024 |
| OptumHealth
Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall
by InfuTronix, LLC 05/30/2024 |
| Vyaire
Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle
Separating During Patient Use 05/23/2024 |
| Hologic,
Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices
05/22/2024 |
| Abbott
Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant
Kit for Risk of Blood Leakage or Air Entering System Between Inflow
Cannula and Apical Cuff 05/15/2024 |
| Philips
Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to
a Software-Related Possible Power Malfunction 05/13/2024 |
| Route
92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the
Proximal Marker Band 05/10/2024 |
| Tandem
Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect
Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ
Technology Prompted by a Software Problem Leading to Pump Battery
Depletion 05/08/2024 |
| BioMérieux
Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations
04/30/2024 |
| SonarMed
Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in
Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To
3mm Distal to the Sensor Tip 04/29/2024 |
| SonarMed
Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter
of Airway Causing Suction Catheter Passage Difficulty 04/29/2024 |
| Elekta
Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic
System for Possibly Containing Microscopic Stainless Steel Debris
on the Inside of the Biopsy Needle 04/26/2024 |
| InfuTronix,
LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple
Device Failures That May Cause Severe Injury and Death 04/25/2024 |
| Draeger,
Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected
Shutdown When Used on Battery Power 04/25/2024 |
| Outset
Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk
of Patient Exposure to Higher Than Allowable Levels of Toxic Compound
NDL-PCBAs 04/25/2024 |
| Fresenius
Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer
Lock Adapter for Risk of Patient Exposure to Higher Than Allowable
Levels of Toxic Compound NDL-PCBA 04/25/2024 |
| DeRoyal
Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley
Under Recall by Nurse Assist 04/24/2024 |
| 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 |
For the most up to date FDA headlines, see the FDA
Medical Device News page.
| 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)
|
|
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
|
|
November 12, 2024
Updated Emergency Use Authorization
- ORAcollect·RNA
OR-100 and ORAcollect·RNA ORE-100 saliva collection devices
(DNA Genotek Inc.)
|
| November 8, 2024
Reclassification
(Updated)
Evaluation
of Airborne Chemicals from Neonatal Incubators - Letter to Health
Care Providers (Updated)
|
|
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.”
|
|
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
|
|
November 5, 2024
Materials
for November 7, 2024 General and Plastic Surgery Devices Panel of
the Medical Devices Advisory Committee Meeting
|
|
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
|
|
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
|
|
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
|
|
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
|
|
October 23, 2024
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A - October 30, 2024
|
|
October 22, 2024
IDE
Application (Updated)
|
|
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
|
|
October 16, 2024
Ventilators
and Ventilator Accessories EUAs (Updated)
CDRH
Petitions (Updated)
|
|
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
|
|
October 10, 2024
CDRH
Proposed Guidance Development (Updated)
CDRH
Proposed Guidances for Fiscal Year 2025 (FY2025)
|
|
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
|
|
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
|
|
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)
|
| September 30, 2024
Safety
and Performance Based Pathway (Updated)
Class
I Recall: Ventilator Correction: Smiths Medical Issues Correction
for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal
Volume Knob Movement
De Novo Classification Order: DEN230067
- Chronos®
De Novo Decision Summaries (Updated)
- DEN220040
- Fibresolve
- DEN220026
- VasQ
- DEN230020
- BioTraceIO Lite
- DEN210056
- ProciseDx Inc.
- DEN230050
- Body Temperature Software (BTS)
- DEN220090
- EasySep™ Human Bone Marrow CD138 Positive Selection Kit
- DEN230012
- Ruthless Spine RJB
- DEN220023
- Procise ADL
|
| September 27, 2024
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A - October 9, 2024
Electronic
Product Radiation Control Program: Industry Guidance (Updated)
Clarification
of Radiation Control Regulations For Manufacturers of Diagnostic
X-Ray Equipment: Guidance for Industry and Food and Drug Administration
Staff
Air
Powered Dental Handpieces and Air Motors - Performance Criteria
for Safety and Performance Based Pathway - Guidance for Industry
and Food and Drug Administration Staff
Dental
Cements - Performance Criteria for Safety and Performance Based
Pathway - Guidance for Industry and Food and Drug Administration
Staff
Dental
Ceramics - Performance Criteria for Safety and Performance Based
Pathway - Guidance for Industry and Food and Drug Administration
Staff
Dental
Impression Materials - Performance Criteria for Safety and Performance
Based Pathway - Guidance for Industry and Food and Drug Administration
Staff
Specific
Test Categories or Technologies: Laboratory Developed Tests FAQs
(Updated)
Federal
Register: Safety and Performance Based Pathway Device-Specific Guidances
Federal
Register: Radiation Control Regulations for Manufacturers of Diagnostic
X-Ray Equipment
Safety
and Performance Based Pathway (Updated)
Webinar:
Labeling Requirements for In Vitro Diagnostic Products (IVD), Including
LDTs, Under 21 CFR 809.10(b), September 24, 2024
- Presentation
- Transcript
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
At-Home
COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
|
|
September 26, 2024
FDA
Digital Health and Artificial Intelligence Glossary - Educational
Resource
|
|
September 24, 2024
Class
I Recall: 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
Medical
Acoustics Program: Research on Medical Acoustic Devices (Updated)
CDRH
Patient Engagement Advisory Committee (Updated)
Federal
Register: Microbiology Devices: Reclassification of Antigen, Antibody,
and Nucleic Acid-Based Hepatitis B Virus Assay Devices
|
|
September 23, 2024
Consumer Information: Altius
Direct Electrical Nerve Stimulation System - P230020
(Neuros Medical, Inc.)
De Novo Decision Summaries Updated:
- DEN230019
- AXIOS Stent and Electrocautery-Enhanced Delivery System
- DEN230002
- DuraGraft Vascular Conduit Solution
- DEN220087
- Edison System
- DEN230021
- ensoETM™
- DEN220078
- Eroxon
|
| September 20, 2024
Revised Emergency Use Authorizations
- OSOM
Flu SARS-CoV-2 Combo Test (SEKISUI Diagnostics, LLC)
- OSOM
Flu SARS-CoV-2 Combo Home Test (SEKISUI Diagnostics, LLC)
- OSOM
Flu SARS-CoV-2 Combo Home Test (SEKISUI Diagnostics, LLC)
Consumer Information: Minima
Stent System - P240003
(Renata Medical)
Reclassification
(Updated)
Class
I Recall: Ventilator Recall: Smiths Medical Removes ParaPAC Plus
Ventilators due to Loosened or Detached Patient Outlet Connector
Accreditation
Scheme for Conformity Assessment (ASCA) (Updated)
The
Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance
for Industry, Accreditation Bodies, Testing Laboratories, and Food
and Drug Administration Staff
Basic
Safety and Essential Performance of Medical Electrical Equipment,
Medical Electrical Systems, and Laboratory Medical Equipment - Standards
Specific Information for the Accreditation Scheme for Conformity
Assessment (ASCA) Program: Guidance for Industry, Accreditation
Bodies, Testing Laboratories, and Food and Drug Administration Staff
Biocompatibility
Testing of Medical Devices - Standards Specific Information for
the Accreditation Scheme for Conformity Assessment (ASCA) Program:
Guidance for Industry, Accreditation Bodies, Testing Laboratories,
and Food and Drug Administration Staff
Federal
Register: Guidance - Accreditation Scheme for Conformity Assessment
Program
Federal
Register: Microbiology Devices - Reclassification of Cytomegalovirus
Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant
Patient Management
Collaborative
Communities with CDRH Participation (Updated)
|
|
September 19, 2024
Chemical
Analysis for Biocompatibility Assessment of Medical Devices - Draft
Guidance for Industry and Food and Drug Administration Staff
Biocompatibility
Assessment Resource Center (Updated)
Federal
Register: Guidance: Chemical Analysis for Biocompatibility Assessment
of Medical Devices
|
|
September 18, 2024
Class
I Recall: 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
Federal
Register: Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Medical
Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User
Fee Cover Sheet, Form 3601a
|
|
September 17, 2024
November
20-21, 2024: Digital Health Advisory Committee Meeting Notice
Zimmer
Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone
Fracture - FDA Safety Communication
Class
I Recall: 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
De Novo Reclassification Order - DEN230067
- Chronos®
De Novo Decision Summaries Updated:
- DEN210055
- N-SWEAT Patch
- DEN220048
- Neoasis
- DEN220033
- MISHA(TM) Knee System
- DEN200029
- Parallel
|
|
September 16, 2024
Updated Emergency Use Authorizations
- OSOM
Flu SARS-CoV-2 Combo Test (SEKISUI Diagnostics, LLC)
- STANDARD
Q COVID-19 Ag Test 2.0 (SD Biosensor, Inc.)
- iHealth
COVID-19/Flu A&B Rapid Test (iHealth Labs, Inc.)
- iHealth
COVID-19/Flu A&B Rapid Test Pro (iHealth Labs, Inc.)
Class
I Recall: Infusion Pump Administration Set Recall: Fresenius Kabi
USA Removes Certain Ivenix Large Volume Pump Primary Administration
Sets
Federal
Register: Digital Health Advisory Committee; Total Product Lifecycle
Considerations for Generative Artificial Intelligence-Enabled Medical
Devices
Federal
Register: Immunology and Microbiology Devices; Classification of
the Quantitative Viral Nucleic Acid Test for Transplant Patient
Management
|
| September 13, 2024
November
7, 2024: General and Plastic Surgery Devices Panel of the Medical
Devices Advisory Committee Meeting Notice
Webinar
- The Voluntary Improvement Program: How to Enroll, Opportunities,
and Best Practices - October 8, 2024
Federal
Register: Medical Devices: Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Clozapine Test System
Federal
Register: Medical Devices: Immunology and Microbiology Devices;
Classification of the Device to Detect or Measure Nucleic Acid from
Viruses Associated with Head and Neck Cancers
Federal
Register: Medical Devices: Therapeutic Devices; Classification of
the Pediatric Continuous Renal Replacement Therapy System
|
|
September 12, 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--ProSense Cryoablation System
|
|
September 10, 2024
Appeal
Options Available to Mammography Facilities Concerning Adverse Accreditation
Decisions, Suspension / Revocation of Certificates, or Patient and
Referring Provider Notification Orders - Guidance for Mammography
Facilities and Food and Drug Administration Staff
Related
Recalls - Plastic Syringes Made in China for Potential Device Failures
(Updated)
Mammography
Quality Standards Act (MQSA) and MQSA Program (Updated)
Important
Information: Final Rule to Amend the Mammography Quality Standards
Act (MQSA) (Updated)
Frequently
Asked Questions About MQSA (Updated)
Facility
Accreditation and Certification (Updated)
The
Annual MQSA Inspection: What Facilities Can Do to Help (Updated)
Mammography
Information for Patients (Updated)
Federal
Register: Medical Devices: Immunology and Microbiology Devices;
Classification of the Whole Exome Sequencing Constituent Device
|
|
September 9, 2024
MedSun Newsletter - September 2024
De Novo(s) Decision Summaries Updated:
- DEN220083
- Stanza
- DEN220059
- NTX100 Tonic Motor Activation (NTX100 ToMAc) System
- DEN220027
- B-R-A-H-M-S sFlt-1/PIGF KRYPTOR Test System
- DEN220058
- BT-001
- DEN220041
- TRISTEL DIO ULT
- DEN230036
- Sepsis ImmunoScore
- DEN200052
- KidneyIntelX.dkd
De Novo Reclassification Order - DEN230090
First To Know Syphilis Test (NOWDiagnostics)
|
|
September 6, 2024
Insulin
Pumps: Tips for Using Your Insulin Pump at Home
Infusion
Pumps: Tips for Using Your Pump at Home
GUDID
Data Trends (Updated)
Augmented
Reality and Virtual Reality in Medical Devices (Updated)
Federal
Register: Gastroenterology-Urology Devices; Classification of the
Endoscopic Pancreatic Debridement Device
Federal
Register: Clinical Chemistry and Clinical Toxicology Devices; Classification
of the Blood Collection Device for Cell-free Nucleic Acids
|
|
September 5, 2024
Incorporating
Voluntary Patient Preference Information over the Total Product
Life Cycle - Draft Guidance for Industry, Food and Drug Administration
Staff, and Other Interested Parties
Webinar
- Draft Guidance: Incorporating Voluntary Patient Preference Information
over the Total Product Life Cycle - October 15, 2024
Webinar
- FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic
Products (IVDs) - October 24, 2024
Laboratory
Developed Tests (Updated)
Patient
Preference Information (PPI) in Medical Device Decision Making (Updated)
Class I Recalls:
- Laryngoscope
Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes,
Updates Use Instructions for Others due to Increased Risk for Battery
Overheat and Explosion
- 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
- Ventilator
Correction: Breas Medical Updates Use Instructions for Vivo 45 LS
due to Potential Elevated Formaldehyde Levels in Newly Manufactured
Ventilators
Federal
Register: Incorporating Voluntary Patient Preference Information
over the Total Product Life Cycle
Federal
Register: Gastroenterology-Urology Devices; Classification of the
Hemodialyzer With Expanded Solute Removal Profile
|
|
September 4, 2024
Influenza
Diagnostic Tests (Updated)
CDRH's
Experiential Learning Program (ELP) (Updated)
Experiential
Learning Program (ELP) Areas of Interest (Updated)
Emergency
Situations (Medical Devices) (Updated)
CLIA
Waiver by Application Decision Summaries (Updated)
Federal
Register: Cardiovascular Devices; Classification of the Adjunctive
Open Loop Fluid Therapy Recommender
Federal
Register: Dental Devices; Classification of the Radiofrequency Toothbrush
Federal
Register: Hematology and Pathology Devices; Classification of the
Heparin and Direct Oral Factor Xa Inhibitor Drug Test System
Federal
Register: Ophthalmic Devices; Classification of the Hydrophilic
Re-Coating Solution
|
|
September 3, 2024
CDRH
Learn: Introduction to Medical Device Recalls
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
MQSA
National Statistics (Updated)
|
| August 30, 2024
CDRH
Learn: Overview of Quality Management System Regulation (New module)
CDRH
Learn: Navigating the Quality Management System Regulation (New
module)
Federal
Register: Dental Devices; Classification of the Neuromuscular Tongue
Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep
Apnea
Federal
Register: Neurological Devices; Classification of the Digital Therapy
Device for Attention Deficit Hyperactivity Disorder
Federal
Register: Orthopedic Devices; Classification of the Intervertebral
Body Graft Containment Device
Federal
Register: Physical Medicine Devices; Classification of the External
Compression Device for Internal Jugular Vein Compression
Medical
Device Sterilization Town Hall: Sterility Master Files and Effective
Use in Premarket Submissions, September 11, 2024
Sterilization
for Medical Devices (Updated)
|
|
August 28, 2024
October
30, 2024: Patient Engagement Advisory Committee Meeting
Voluntary
Malfunction Summary Reporting (VMSR) Program for Manufacturers -
Guidance for Industry and Food and Drug Administration Staff
Voluntary
Malfunction Summary Reporting Program
CDRH
Patient Engagement Advisory Committee (Updated)
De Novo Decision Summaries added:
- DEN230008
- DEN210035
- DEN190038
- DEN220082
- DEN210039
- DEN190035
- DEN230007
- DEN220063
- DEN220065
- DEN200011
- DEN220044
- DEN210022
- DEN200067
- DEN210027
- DEN200062
Federal
Register: Hearings, Meetings, Proceedings, etc.: Patient Engagement
Advisory Committee; Patient-Centered Informed Consent in Clinical
Study
Federal
Register: Medical Devices and Device-led Combination Products: Voluntary
Malfunction Summary Reporting for Manufacturers
Federal
Register: Guidance: Voluntary Malfunction Summary Reporting Program
for Manufacturers
|
|
August 27, 2024
Consumer Information: ColoSense
– P230001
Presentation
and Transcript added for In Vitro Diagnostic Products (IVDs) - MDR
Requirements, Correction and Removal Reporting Requirements, and
Quality System Complaint Requirements - 08/22/2024
CDRH
Management Directory by Organization (Updated)
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
Patient
Engagement Advisory Committee; Patient-Centered Informed Consent
in Clinical Study
|
|
August 26, 2024
eMDR
System Enhancements (Updated)
Coding
Resources for Medical Device Reports (Updated)
Health
Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files
(Updated)
MDR
Data Files (Updated)
Voluntary
Recall of SoClean Equipment Intended for Use with CPAP Devices and
Accessories: FDA Safety Communication (Updated)
Federal
Register: Mammography Quality Standards Act and Regulation Amendments:
Small Entity Compliance Guide; Guidance for Industry and Food and
Drug Administration Staff; Availability
Federal
Register: Withdrawal of Approval and Amending of Mammography Quality
Standards Act Alternative Standards
|
|
August 23, 2024
Revoked Emergency Use Authorizations
- Procleix
SARS-CoV-2 Assay (Grifols Diagnostic Solutions Inc.)
- LumiraDx
SARS-CoV-2 RNA STAR (LumiraDx UK Ltd.)
Mammography
Quality Standards Act and Regulation Amendments: Small Entity Compliance
Guide - Guidance for Industry and Food and Drug Administration Staff
Mammography
Quality Standards Act and Program (Updated)
Federal
Register: Authorization of Emergency Use of Certain Medical Devices
During COVID-19; Availability
Federal
Register: Electronic Submission Template for Medical Device De Novo
Requests
Webinar
– Final Guidance: Remanufacturing of Medical Devices
At-Home
COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Class
I Recall: 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
|
|
August 22, 2024
Electronic
Submission Template for Medical Device De Novo Requests - Guidance
for Industry and Food and Drug Administration Staff
FDA
and Industry Procedures for Section 513(g) Requests for Information
under the Federal Food, Drug, and Cosmetic Act - Guidance for Industry
and Food and Drug Administration Staff
Federal
Register: Predetermined Change Control Plans for Medical Devices;
Draft Guidance for Industry and Food and Drug Administration Staff;
Availability
Class
I Recall: Chest Compression Device Recall: Defibtech, LLC, Removes
RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping
Compressions
|
|
August 21, 2024
Updated Emergency Use Authorization
- Influenza
SARS-CoV-2 (Flu SC2) Multiplex Assay (Centers for Disease Control
and Prevention (CDC))
CDRH
Petitions (Updated)
Webinar
– Draft Guidance: Predetermined Change Control Plans for Medical
Devices
510(k)
Third Party Performance Metrics and Accreditation Status (Updated)
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
Predetermined
Change Control Plans for Medical Devices - Draft Guidance for Industry
and FDA Staff
|
|
August 20, 2024
Division
of Industry and Consumer Education Educational Newsletter - August
2024External Link Disclaimer
Class
I Recall: 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
Acceptable
Media for Electronic Product User Manuals - Guidance for Industry
and FDA Staff
|
|
August 19, 2024
Consumer Information: BD
Onclarity HPV Assay - P160037/S017
(Becton, Dickinson and Company)
For Classification: SoClean
3+ Bacterial Reduction Device - DEN210037
(SoClean, Inc.)
|
| August 15, 2024
CDRH
FOIA: How to Get Records from CDRH (Updated)
Pediatric
and Perinatal Devices Program: Research of Pediatric and Perinatal
Devices
Federal
Register: General Hospital and Personal Use Devices; Classification
of the Intravenous Catheter Force-Activated Separation Device
Federal
Register: Immunology and Microbiology Devices; Classification of
the Device To Detect and Identify Nucleic Acid Targets Including
SARS-CoV-2 in Respiratory Specimens
Federal
Register: Immunology and Microbiology Devices; Classification of
the Device to Detect and Identify Selected Microbial Agents That
Cause Acute Febrile Illness
|
|
August 14, 2024
Webinar
- Labeling Requirements for In Vitro Diagnostic Products (IVD),
Including LDTs, Under 21 CFR 809.10(b) - September 24, 2024
|
|
August 13, 2024
Revised Emergency Use Authorization
- cobas
liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (Roche
Molecular Systems, Inc.)
New Emergency Use Authorization
- Flowflex
Plus COVID-19 and Flu A/B Home Test (ACON Laboratories, Inc.)
Consumer
Information: Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 RESILIA
Transcatheter Heart Valve System - P140031/S162
(Edwards Lifesciences, LLC)
|
|
August 12, 2024
CDRH
Petitions (Updated)
For Classification: VerTouch
Spinal Imaging Device - DEN220009
(IntuiTap Medical, Inc.)
For Classification: PGDx
elio plasma focus Dx - DEN230046
(Personal Genome Diagnostics, Inc.)
|
| August 8, 2024
Revoked Emergency Use Authorizations
- Sampinute
COVID-19 Antigen MIA (Celltrion USA, Inc.)
- Celltrion
DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
- Celltrion
DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
- cobas
SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas
SARS-CoV-2) (Roche Molecular Systems)
- LumiraDx
SARS-CoV-2 & Flu A/B RNA STAR Complete Assay (LumiraDx UK Ltd.)
MedSun
Newsletter - August 2024
|
|
August 7, 2024
Updated Emergency Use Authorization
- SalivaDirect
DTC Saliva Collection Kit (SalivaDirect, Inc.)
Artificial
Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
(Updated)
|
|
August 6, 2024
Class I Recalls
- 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
-Nerve
Monitoring System Correction: Medtronic Issues Correction for NIM
Vital Nerve Monitoring System due to the Potential for False Negative
Response
|
|
August 5, 2024
Discussion
Paper: Health Equity For Medical Devices
CDRH
Strategic Priorities and Updates (Updated)
Risks
with Exactech Joint Replacement Devices with Defective Packaging
- FDA Safety Communication (Updated)
|
|
August 2, 2024
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
|
|
August 1, 2024
Reprocessing
Single-Use Medical Devices: Information for Health care Facilities
Reprocessed
Single-Use Devices: Frequently Asked Questions
MQSA
National Statistics (Updated)
Medical
Device User Fee Amendments (MDUFA) (Updated)
Device
Registration and Listing (Updated)
|
| July 31, 2024
Safe
Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes
– Letter to Health Care Providers
|
|
July 30, 2024
Federal
Register: Medical Device User Fee Rates for Fiscal Year 2025
|
| July 29, 2024
MagDI
System - DEN240013
(GT Metabolic Solution, Inc.)
Simplexa
C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa
C. auris Sample Prep Kit - DEN230092
(DiaSorin Molecular LLC)
Terragene
Bionova Photon Biological Indicator (BT225);Terragene Bionova Photon
Auto-Reader Incubator (BPH) - DEN220042
(Terragene SA)
In
situ polymerizing peripheral nerve cap - DEN230061
(Tulavi Therapeutics)
|
|
July 26, 2024
Updated Emergency Use Authorization
-
Nano-Check Influenza+COVID-19 Dual Test (Nano-Ditech Corporation)
|
|
July 25, 2024
Digital Health Blog: A
Lifecycle Management Approach toward Delivering Safe, Effective
AI-enabled Health Care
|
|
July 24, 2024
Reissued Emergency Use Authorization
- Labcorp
Monkeypox PCR Test Home Collection Kit (Labcorp)
Medical
Device Sterilization Town Hall: Short Topics and Open Q&A, August
7, 2024
Sterilization
for Medical Devices (Updated)
Federal
Register: Emergency Use Authorization: Certain Medical Devices during
COVID-19
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
|
|
July 23, 2024
New Emergency Use Authorization
- Nano-Check
Influenza+COVID-19 Dual Test (Nano-Ditech Corporation)
Consumer Information: Occlutech
ASD Occluder and Occlutech Pistol Pusher - P200032
(Occlutech Holding AG)
RefleXion
Medical Radiotherapy System - DEN220014
(RefleXion Medical Inc.)
BioXmark
- DEN220017
(Nanovi A/S)
|
| July 18, 2024
Public
Workshop –Accreditation Scheme for Conformity Assessment and
Use of Chemical Analysis to Support Biocompatibility of Medical
Devices - 11/06/2024
Standards
Newsletter from the Division of Standards and Conformity AssessmentExternal
Link Disclaimer (July 2024)
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
ASCA-Accredited
Testing Laboratories (Updated
|
|
July 17, 2024
Updated Emergency Use Authorization
- CDC
Novel Coronavirus 2012 Real-time RT-PCR Assay (CDC)
|
|
July 16, 2024
CDRH
Petitions (Updated)
Continuous
Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions
for OmniLab Advanced+ (OLA+) Ventilator due to Interruptions and/or
Loss of Therapy (Updated)
|
|
July 15, 2024
CDRH
Statement: CDRH Announces Reorganization of Several Offices to Increase
Organizational Agility and Advance Public Health Mission
Class I Recall:
- Ventilator
Recall: Baxter Removes Life2000 Ventilator Due to Potential Failure
of Battery Charging Dongle
- Eye
Injection Kit Recall: Bausch + Lomb/Synergetics Inc. Removes Certain
I-Pack Injection Kits Due to Potential Non-Sterility
|
|
July 11, 2024
Updated Emergency Use Authorizations
- Genabio
COVID-19 Rapid Self-Test Kit (Genabio Diagnostics, Inc.)
-
MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical,
Inc.)
Dental
Composite Resin Devices - Premarket Notification (510(k)) Submissions
- Draft Guidance for Industry and FDA Staff
Dental
Curing Lights - Premarket Notification (510(k)) Submissions - Draft
Guidance for Industry and FDA Staff
Class
I Recall: Ventilator Software Correction: Hamilton Medical Issues
Correction for HAMILTON-C6 Medical Ventilators to Address Risk of
Failed Ventilation Restart
UGA/FDA
11th Annual Medical Device Regulations Conference - August 21, 2024
Current
Career Opportunities at CDRH (Updated)
Federal
Register: Clinical Considerations for Studies of Devices Intended
to Treat Opioid Use Disorder
Federal
Register: Dental Composite Resin Devices and Dental Curing Lights-Premarket
Notification (510(k)) Submissions Guidances
|
|
July 10, 2024
Clinical
Considerations for Studies of Devices Intended to Treat Opioid Use
Disorder - Guidance for Industry and FDA Staff
Disruptions
in Availability of BD BACTEC Blood Culture Media Bottles - Letter
to Health Care Providers
Medical
Device Shortages List (Updated)
Webinar
- In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction
and Removal Reporting Requirements, and Quality System Complaint
Requirements - August 22, 2024
Continuous
Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions
for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or
Loss of Therapy (Updated)
|
|
July 9, 2024
Do
Not Use Medtronic NIM Standard and Contact EMG Endotracheal Tubes
- Letter to Health Care Providers
|
|
July 8, 2024
Revoked Emergency Use Authorization
- cobas
SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the
cobas Liat System (Roche Molecular Systems, Inc.)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
MedSun
Newsletter - July 2024
Class
I Recall: 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
Class
I Recall: 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
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Reclassification Petitions for Medical Devices
|
|
July 5, 2024
Reissued Emergency Use Authorizations
- SalivaDirect
DTC Saliva Collection Kit (SalivaDirect, Inc.)
- SalivaDirect
At-Home Collection Kit (SalivaDirect, Inc.)
Updated Emergency Use Authorizations
- Advin
COVID-19 Antigen Test @Home (Advin Biotech Inc.)
- WELLlife
COVID-19 / Influenza A&B Test (Wondfo USA Co., Ltd.)
- WELLlife
COVID-19 / Influenza A&B Home Test (Wondfo USA Co., Ltd.)
REdI
Conference (Updated)
|
|
July 3, 2024
Reissued Emergency Use Authorizations
- SalivaDirect
(SalivaDirect, Inc.)
- SalivaDirect
for use with DTC Kits (SalivaDirect, Inc.)
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
in Response to an Outbreak of Mpox
Federal
Register: Emergency Use Authorization: Monkeypox Polymerase Chain
Reaction Test Home Collection Kit in Response to an Outbreak of
Mpox
|
|
July 2, 2024
Public
Workshop - Food and Drug Administration/National Institutes of Health
Joint Workshop: Developing Implanted Brain-Computer Interface Clinical
Outcome Assessments to Demonstrate Benefit, September 19 and 20,
2024
|
|
July 1, 2024
CDRH
Statement: CDRH Announces Expansion of the Total Product Life Cycle
Advisory Program
Total
Product Life Cycle Advisory Program (TAP) (Updated)
|
| June 28, 2024
Class I Recall:
- Left
Ventricular Assist System (LVAS) Monitor Correction: Abbott Medical
Issues Correction for HeartMate LVAS System Monitor due to Screen
Issues that May Cause Unintentional Pump Stop
- Continuous
Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions
for OmniLab Advanced+ (OLA+) Ventilator due to Interruptions and/or
Loss of Therapy
Exemptions
From Electronic Product Regulations (Updated)
|
|
June 27, 2024
Revised Emergency Use Authorizations
- AdviseDx
SARS-CoV-2 IgG II - Abbott Laboratories Inc.
Updated Emergency Use Authorizations
- Cobas
liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test - Roche
Molecular Systems, Inc.
Class I Recall:
- Continuous
Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions
for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or
Loss of Therapy
- Ventilator
Correction: ZOLL Medical Corporation Updates Use Instructions For
731 Ventilators Due to Missing MRI Safety Information in The Labeling
That May Lead to Misuse and Ventilator Failure
Federal
Register: Diversity Action Plans To Improve Enrollment of Participants
From Underrepresented Populations in Clinical Studies; Draft Guidance
for Industry; Availability
|
|
June 26, 2024
eSTAR
Program (Updated)
CDRH
Announces Partnership to Develop New Methods to Accelerate Diagnostic
Device Development for Underserved Populations
Explore
Life at CDRH (Updated)
Medical
Device Sterilization Town Hall: Mock Pre-Submission on Implementing
a Change in Sterilization Method - July 10, 2024
|
|
June 25, 2024
Federal
Register: Laboratory Developed Tests: Small Entity Compliance Guide;
Guidance for Laboratory Manufacturers and Food and Drug Administration
Staff; Availability
|
|
June 24, 2024
Laboratory
Developed Tests: Small Entity Compliance Guide - Guidance for Laboratory
Manufacturers and Food and Drug Administration Staff
CDRH
Patient and Caregiver Connection (Updated)
|
| June 21, 2024
Consumer Information: LIAISON
Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus
B19 IgG Plus - P220034
(DiaSorin Inc.)
Consumer Information:
TriClip G4 System - P230007
(Abbott Medical)
Consumer Information: INTELLANAV
STABLEPOINT Ablation Catheter & Force Sensing System on The
RHYTHMIA HDX Mapping System - P150005/S074
(Boston Scientific Corporation)
|
|
June 20, 2024
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Home
as a Health Care Hub
Virtual
Public Meeting – Home as a Health Care Hub – Stakeholder
Listening Session; July 25, 2024
|
|
June 18, 2024
Consumer Information: Vercise
PC, Vercise Gevia, and Vercise Genus Deep Brain Stimulation Systems
- P150031/S064
(Boston Scientific Corporation)
Consumer Information: FoundationOne
CDx (F1CDx) - P170019/S048
(Foundation Medicine, Inc.)
Digital
Health Reports (Updated)
Laboratory
Developed Tests (Updated)
|
|
June 17, 2024
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
Blog:
The Promise Artificial Intelligence Holds for Improving Health Care
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
|
| June 14, 2024
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Consumer Information: AGENT
Paclitaxel-Coated Ballon Catheter - P230035
(Boston Scientific Corporation)
|
|
June 13, 2024
New Emergency Use Authorizations
- Healgen
COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) (Healgen
Scientific, LLC)
- Speedy
Swab Rapid COVID-19 + Flu A&B Antigen Self-Test (Watmind USA)
Transparency
for Machine Learning-Enabled Medical Devices: Guiding Principles
CDRH
Statement: CDRH Issues Guiding Principles for Transparency of Machine
Learning-Enabled Medical Devices
Class I Recall:
- Teleflex/Arrow
International Recall Arrow FiberOptix and UltraFlex Intra-Aortic
Balloon (IAB) Catheter Kits for Manufacturing Issue That May Prevent
Full Balloon Inflation and Cause Patient Harm
- Getinge
Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient
and Health Care Professional Exposure to Toxic Chemical Hydrogen
Fluoride
- Electrode
Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient
Return Electrodes for Risk of Serious Burn Injuries to Patients
|
|
June 12, 2024
Consumer Information: Alinity
m HR HPV for use on Alinity m System - P230003
(Abbott Molecular, Inc.)
Federal
Register: Request for Nominations for Individuals and Consumer Organizations
for Advisory Committees
|
|
June 11, 2024
New Emergency Use Authorizations
- iHealth
COVID-19/Flu A&B Rapid Test Pro (iHealth Labs, Inc.)
- cobas
liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (Roche
Molecular Systems, Inc.)
Updated Emergency Use Authorizations
- CorDx
TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test (CorDx,
Inc.)
Addressing
the Limitations of Medical Data in AI
Identifying
and Measuring AI Bias for Enhancing Health Equity
Evaluation
Methods for AI-enabled Medical Devices: Performance Assessment and
Uncertainty Quantification
Performance
Evaluation Methods for Evolving AI-Enabled Medical Devices
Regulatory
Evaluation of New Artificial Intelligence AI Uses for Improving
and Automating Medical Practices
Methods
for Effective Post-market Monitoring of AI-Enabled Medical Devices
eMDR
System Enhancements (Updated)
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Class
I Recall: Endotracheal Tube Recall: Medline Industries, LP Removes
Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to
Detachment or Tearing of the Inflation Tube from the Main Tube
Presentation
and Transcript added to Webinar - Enforcement Policies for Certain
In Vitro Diagnostic Devices - Draft Guidances, June 5, 2024
|
|
June 10, 2024
Artificial
Intelligence Program: Research on AI/ML-Based Medical Devices (Updated)
|
|
June 7, 2024
MedSun
Newsletter - June 2024
|
|
June 6, 2024
About
Manufacturer and User Facility Device Experience (MAUDE) Database
(Updated)
|
|
June 5, 2024
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
At-Home
COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
Class
I Recall: Medtronic Recalls StealthStation S8 Application Versions
1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 for Software Error that May
Cause Incorrect Measurements During Cranial Surgery
|
|
June 4, 2024
Revised Emergency Use Authorizations
- CorDx
Tyfast Flu A/B & COVID-19 Multiplex Rapid Test (CorDx, Inc.)
Consumer Information: TheraBionic
P1 - H220001
(TheraBionic, Inc.)
510(k)
Third Party Performance Metrics and Accreditation Status (Updated)
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Device Recall Authority
|
|
June 3, 2024
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
|
|
|
