CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
September 23, 2024
- Consumer Information: Altius Direct Electrical Nerve Stimulation System - P230020 (Neuros Medical, Inc.)
- De Novo Decision Summaries Updated:
September 20, 2024
- Revised Emergency Use Authorizations
- 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
- Collaborative Communities with CDRH Participation (Updated)
- 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
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- Chemical Analysis for Biocompatibility Assessment of Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff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:
September 16, 2024
- Updated Emergency Use Authorizations
- 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
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:
- 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
August 30, 2024
- CDRH Learn: Overview of Quality Management System Regulation (New module)
- CDRH Learn: Navigating the Quality Management System Regulation (New module)
- Medical Device Sterilization Town Hall: Sterility Master Files and Effective Use in Premarket Submissions, September 11, 2024
- Sterilization for Medical Devices (Updated)
- 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
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 Updated:
- DEN230008 - DermaSensor
- DEN210035 - GeniusTM Digital Dignostics System with the GeniusTM Cervical AI algorithm
- DEN190038 - Surfacer Inside-Out Access Catheter System
- DEN220082 - Bateman Bottle
- DEN210039 - SNOO Smart Sleeper
- DEN190035 - Helix Laboratory Platform
- DEN230007 - LightStrike+
- DEN220063 - Caption Interpretation Automated Ejection Fraction Software
- DEN220065 - Pill Sense System
- DEN200011 - Masimo SafetyNet Opioid System
- DEN220044 - Active Anthrax Detect Plus Rapid Test
- DEN210022 - PMD-200
- DEN200067 - INNOVANCE VWF Ac
- DEN210027 - The Cooral System
- DEN200062 - Parsortix® PC1 device
- 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
- Consumer Information: cobas HPV for 5800/6800/8800 Systems - P190028/S009 (Roche Molecular Systems, Inc.)
- Consumer Information: cobas HPV Test for use on the cobas 4800 System - P100020/S055 (Roche Molecular Systems, Inc.)
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
- 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)
- 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
- 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
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
- Class I Recall: Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping Compressions
- Federal Register: Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
August 21, 2024
- Updated Emergency Use Authorization
- 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 2024
- 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
August 13, 2024
- Revised Emergency Use Authorization
- New Emergency Use Authorization
- 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
- 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
August 1, 2024
July 31, 2024
July 30, 2024
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
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
- 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
- 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 Assessment (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
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:
July 11, 2024
- Updated Emergency Use Authorizations
- 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
July 8, 2024
- Revoked Emergency Use Authorization
- 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
- Updated Emergency Use Authorizations
- REdI Conference (Updated)
July 3, 2024
- Reissued Emergency Use Authorizations
- 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