CDRH New - News and Updates
October 2, 2026
October 1, 2026
- CDRH Proposed Guidances for Fiscal Year 2027 (FY 2027)
- Contact Us – Office of Industry and Consumer Education (OICE) (Updated)
- FDA Approves First Heart Valve Designed to Grow with Children
September 30, 2026
September 29, 2026
- FDA READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home (Updated)
- Federal Register: Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature
September 28, 2026
September 25, 2026
September 24, 2026
- Robotic Medical Devices
- Public Workshop: Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities
- Robotically-Assisted Surgical Devices - Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules
- Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers
- Federal Register: Robotically-Assisted Surgical Devices-Premarket Submissions
September 23, 2026
- Early Alert: Heart Pump Controller Issue from Abiomed
- Early Alert: Ventilator Issue from React Health
September 22, 2026
September 21, 2026
- Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets (Updated)
- Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride Ampules (Updated)
- Meeting Materials: September 23, 2026 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting
- eSTAR Program (Updated)
September 18, 2026
- Nitric Oxide Delivery System Correction: NOxBOX Updates Use Instructions for NOxBOXi Nitric Oxide Delivery System (Updated)
- Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules
September 17, 2026
- Electronic Submission Template for Premarket Approval Applications (PMA) - Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Guidance: Electronic Submission Template for Medical Device Premarket Approval Applications
- Town Hall – Biocompatibility Risk Assessment September 9, 2026 (Updated)
- CDRH Learn (Updated)
September 16, 2026
- CDRH Learn Module: Introduction to Medical Device Development Tools (MDDTs) (Specialty Technical Topics)
- Federal Register: Medical Devices; Exemption from Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
September 15, 2026
- Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device
- Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - November 19, 2026
- Federal Register: Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments --- Pathogen-agnostic sequencing
September 14, 2026
- CDRH Patient Engagement Courses (Updated)
- CDRH Patient Education Program Course 2 Video: “Patient-Generated and Real-World Data Throughout the Medical Device Life Cycle
- CDRH Regulatory Reliance Portal for Medical Devices
September 10, 2026
- Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program (Updated)
- Table of Pharmacogenetic Associations (Updated)
- MQSA Certificate Delivery Process
- Epidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine Ampules
- Federal Register: Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
- Federal Register: Medical Device Tracking
September 9, 2026
- Clear Dental Aligners
- Biocompatibility Updates
- Federal Register: Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access
- Federal Register: Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
- Federal Register: Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
- Federal Register: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease
- Federal Register: Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery
- Federal Register: Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device
- Federal Register: General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
- Federal Register: Radiology Devices; Classification of the Vaginal Hydrogel Packing System
September 4, 2026
- Artificial Intelligence-Enabled Medical Devices (Updated)
- Augmented Reality and Virtual Reality in Medical Devices (Updated)
- Medical Devices that Incorporate Sensor-based Digital Health Technology (Updated)
- MQSA National Statistics (Updated)
September 3, 2026
- Early Alert: Breathing Circuit Issue from Drager
- Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Leads
- Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software (Updated)
September 2, 2026
- Early Alert: Convenience Kit Issue from AVID Medical
- Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing BD ChloraPrep Applicators (Updated)
- Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters (Updated)
September 1, 2026
- Breathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing Circuits
- Dental Curing Lights - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff
- Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff
- PFAS in Medical Devices: What You Need to Know (Updated)
- September 2026 MedSun Newsletter
- Federal Register: Dental Composite Resin Devices and Dental Curing Lights--Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability
August 28, 2026
- Early Alert: Angiographic Catheter Issue from Boston Scientific
- Early Alert: IV Start Kit Issue from Avid Medical
- Mammography Problems at Mammography Center of Monterey in Monterey, California: FDA Safety Notification
- 510(k) Third Party Performance Metrics and Accreditation Status (Updated)
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Reports of Removals and Corrections
August 27, 2026
- Transcript and Presentation: FDA’s public meeting on the Reauthorization of the Medical Device User Fee Amendments
- Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Medline Namic Star Off Handle Manifolds
- Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging
- Federal Register Notices for Modifications to the List of Recognized Standard (Updated)
- Listing of CDRH Humanitarian Device Exemptions (Updated)
- CDRH Learn (Updated)
August 26, 2026
- Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System
- Early Alert: Heart Pump Controller Purge Cassette Issue from Abiomed
- CDRH Issues Proposed List of Accessories Suitable for Distinct Classification as Devices (Updated)
- MDUFA Quarterly Performance Report (Updated)
August 25, 2026
- FDA READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home
- FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
- Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
August 24, 2026
- Early Alert: Convenience Kit Issue from Medline
- Early Alert: Convenience Kit Issue from AVID Medical
- Early Alert: Ventilator Issue from CooperSurgical
- Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
August 21, 2026
- Participants Selected for TEMPO for Digital Health Devices Pilot (Updated)
- MDR Adverse Event Codes (Updated)
- How to Code an MDR Adverse Event Report (Updated)
- Early Alert: Epidural Kit Issue from Medical Action Industries
- Early Alert: Portrait Mobile Monitoring Software Issue from GE HealthCare
- Early Alert: Breathing Circuit Issue from Medline
- Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066
August 20, 2026
- Key Considerations for the Development and Use of Digitally Derived Measures for Clinical Investigations, FDA Paper
- Power Morcellation During Gynecologic Laparoscopic Surgeries
- Convenience Kit Recall: Medline Issues Correction for Convenience Kits Containing B. Braun Bupivacaine Hydrochloride Components
- Coding Resources for Medical Device Reports
August 19, 2026
August 18, 2026
- Early Alert: Convenience Kit Issue from Becton Dickinson
- Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback
August 17, 2026
- Reclassification (Updated)
- Intraosseous Needle Set Recall: Becton Dickinson Removes Certain Intraosseous Vascular Access System Needle Sets (Updated)
- Participants Selected for TEMPO for Digital Health Devices Pilot (Updated)
August 14, 2026
- Federal Register: Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product
- Federal Register: Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
- Federal Register: Medical Devices: Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I
August 13, 2026
August 12, 2026
- Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing ICU Medical Pain Management Components
- Update on Alert: Convenience Kit Issue from Medline
August 10, 2026
- Catheter Introducer Correction: Abiomed and Oscor Issue Correction for Catheter Introducer
- Breathing Circuit Set Recall: Hamilton Medical Removes Breathing Circuit Set (Updated)
August 7, 2026
- MQSA National Statistics (Updated)
- Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement - September 23, 2026
- Federal Register: Reclassification of Digital Breast Tomosynthesis System
- Federal Register: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Establishment of a Public Docket, GRAIL, Inc. Galleri
August 6, 2026
- CDRH Patient and Caregiver Connection (Updated)
- Public Meeting: Regulatory Science Innovations Catalyzing Medical Device Development - September 25, 2026
August 5, 2026
- Participants Selected for TEMPO for Digital Health Devices Pilot (Updated)
- August 2026 MedSun Newsletter
- Federal Register: Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System
- Federal Register: Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox
August 4, 2026
August 3, 2026
- eSTAR Program (Updated)
- Content of Human Factors Information in Medical Device Marketing Submissions
- Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers (Updated)
- Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injection
- Convenience Kit Correction: Medical Action Industries Issues Correction for Kits Containing Recalled Namic Manifolds
July 31, 2026
- Ventilator Correction: Resmed Issues Correction for Astral Ventilator
- Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer Kits
July 30, 2026
- Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine Ampules
- Presentation, Slides, and Transcript posted for Town Hall – Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance - July 22, 2026
- Medical Device User Fee Amendments (MDUFA): Fees (Updated)
July 28, 2026
July 24, 2026
- Early Alert: Percutaneous Catheter Issue from Boston Scientific
- Federal Register: Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction
- Federal Register: General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators
July 23, 2026
- Getting a Radiation Emitting Product to Market: Frequently Asked Questions (Updated)
- List of FDA-Authorized Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
- Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression
- Federal Register: General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device
- Federal Register: Immunology and Microbiology; Classification of the Over-the-Counter Test to Detect SARS-CoV-2 from Clinical Specimens
- Federal Register: Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool
July 22, 2026
- Participant Selected for TEMPO for Digital Health Devices Pilot
- TEMPO for Digital Health Devices Pilot (Updated)
July 20, 2026
July 17, 2026
- Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System (Updated)
- Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer Kits
July 16, 2026
- Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
- Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline
- Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Voluntary Improvement Program
- Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program
July 15, 2026
- Early Alert: Ventilator Issue from Resmed
- Town Hall – Biocompatibility and Toxicological Risk Assessment
- Town Hall – Biocompatibility and Chemical Characterization Testing - Extractions
- Town Hall – Biocompatibility Risk Assessment
July 14, 2026
- Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices
- Reports on Non-Device Software Functions (Updated)
July 13, 2026
- Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Catheter Delivery Catheter System (DCS)
- Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program (Updated)
- 510(k) Third Party Performance Metrics and Accreditation Status (Updated)
July 9, 2026
- Presentation, Slides, and Transcript added to Webinar – Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge, June 24, 2026
- Early Alert: Convenience kits Issue from Medline
- Early Alert: Convenience Kit Issue from Medical Action Industries
July 7, 2026
- MQSA National Statistics (Updated)
- July 2026 MedSun Newsletter
- Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
- Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
- Register for the FDA’s public meeting on the Reauthorization of the Medical Device User Fee Amendments
- Medical Device User Fee Amendments 2028 (MDUFA VI)
- Register for the FDA’s public meeting on the Reauthorization of the Medical Device User Fee Amendments - 2025 (Updated)
- Federal Register: Medical Device User Fee Amendments; Public Meeting; Request for Comments
July 6, 2026
- Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
- Biocompatibility and Toxicology Program: Research on Medical Devices, Biocompatibility, and Toxicology (Updated)
- Menstrual Product Options, Facts, and Safe Use
- Menstrual Cups
- Menstrual Pads and Liners
- Tampons
- Cybersecurity News and General Resources (Updated)
July 2, 2026
- Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
- Insulin Pump Recall: Insulet Removes Omnipod Pods
- Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
July 1, 2026