CDRH New - News and Updates
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)
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
June 30, 2026
June 29, 2026
- Clinical Decision Support Software Frequently Asked Questions (FAQs) (Updated)
- Federal Register: Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
- Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
June 26, 2026
- First Aid Kit Recall: North American Rescue Issues Correction for First Aid Kits Containing TRUE METRIX Devices
- eMDR System Enhancements (Updated)
- Federal Register: Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber
June 25, 2026
- Notifications on Data Integrity – Medical Devices
- Federal Register: Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
- Federal Register: General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System
- Federal Register: General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant
- Federal Register: General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System
- Federal Register: Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
- Federal Register: Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms
- Federal Register: Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome
June 22, 2026
- Heart Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers (Updated)
- Infant Resuscitation System Correction: GE HealthCare Issues Correction for Giraffe and Panda Infant Resuscitation Systems and Warmers with a M1091607-R Blender
June 18, 2026
- Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters (Updated)
- Early Alert: Catheter Introducer Issue from Abiomed and Oscor
- Federal Register: Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device
- Federal Register: Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device
- Federal Register: Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples
June 17, 2026
- FDA READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home (Updated)
- READI-Home Innovation Challenge Frequently Asked Questions
June 16, 2026
- Disruptions in Availability of Breast Biopsy Needles - Letter to Health Care Providers
- Medical Device Shortages List (Updated)
- Early Alert: Convenience Kit Issue from Windstone Medical Packaging, Inc.
- 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)
- Federal Register: Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule
- Federal Register: Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
June 15, 2026
- Anesthesia Machine Correction: Draeger, Inc. Issues Correction for Atlan A350 and A350XL Anesthesia Workstations
- Warning Letter: Happiest Baby, Inc.
- Pediatric Medical Devices (Updated)
June 12, 2026
June 11, 2026
- Early Alert: Positive Pressure Breathing Device Issue from Baxter
- Heart Pump Correction: Abiomed Issues Correction for Automated Impella Controllers
June 10, 2026
- Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System
- Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings
June 9, 2026
June 8, 2026
June 5, 2026
- Early Alert: Infant Resuscitation System Issue from GE HealthCare
- Breakthrough Devices: Program Metrics and Marketing Authorizations List Updated
June 4, 2026
- Early Alert: Insulin Pump Issue from Insulet
- Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements - Guidance for Industry and Food and Drug Administration Staff
- June 2026 MedSun Newsletter
- Federal Register: Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head / Metallic Stem Cemented or Uncemented Prosthesis
- Federal Register: Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial
- Federal Register: Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener
- Federal Register: Guidance: Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements
June 3, 2026
- UPDATE: Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication
- Anesthesia Kit Correction: Becton Dickinson Issues Correction for BD Spinal Trays Containing Bupivacaine Ampules
June 2, 2026
- CDRH and Real-World Evidence
- Early Alert: Catheter Introducer Kit Issue from Abiomed
- CDRH Patient Engagement Courses (Updated)
- CDRH Patient Education Program Course Video: Patients as Advisors in Medical Device Clinical Studies
June 1, 2026
- eSTAR Program (Updated)
May 29, 2026
- Recognized Consensus Standards: Medical Devices (Updated)
- Town Hall – Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance - July 22, 2026
- eMDR System Enhancements (Updated)
- Pediatric Care Bed Correction: KayserBetten Issues Correction for KayserBett IDA Beds
- Federal Register: Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology
- Federal Register: Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia
- Federal Register: Dental Devices; Classification of the Intraoral Cooling Device
- Federal Register: Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator
- Federal Register: Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
- Federal Register: General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container with Electronic Monitoring
- Federal Register: Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay
May 28, 2026
- Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators
- Cryoprobe Recall: Erbe USA Removes Flexible Cryoprobes (Updated)
- Human Factors and Medical Devices (Updated)
- Content of Human Factors Information in Medical Device Marketing Submissions - Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Content of Human Factors Information in Medical Device Marketing Submissions
- Federal Register: Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Fibromyalgia Symptoms
May 27, 2026
- Early Alert: Heart Pump Issue from Abiomed
- Early Alert: IV Tubing Set Issue from ICU Medical
- Federal Register: Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss
- FDA Recognized Consensus Standards: Medical Devices (Updated)
May 26, 2026
- Manifold Recall: Medline Removes Namic Star Off Handle Manifolds
- 2nd Quarter FY2026 MDUFA V Performance Report
- Dialysis Catheter Kit Recall: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers (Updated)
May 21,2026
- Automated Compounding System Recall: Omnicell Removes Syringe Labels Used with the i.v.STATION Automated Compounding System
- Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators
- Early Alert: Heart Pump Controller Issue from Abiomed
May 20, 2026
May 19, 2026
- Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems (Updated)
- Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication (Updated)
- Experiential Learning Program (ELP) Areas of Interest (Updated)
May 18, 2026
May 15, 2026
May 12, 2026
- Convenience Kit Recall: AVID Medical Removes Convenience Kits Containing Namic RA Syringes
- Center for Devices and Radiological Health (CDRH) Compliance Programs
May 11, 2026
- eMDR System Enhancements
- Convenience Kit Recall: Aligned Medical Solutions Removes Convenience Kits Containing Namic RA Syringes
- Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection
May 7, 2026
- Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps
- Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication (Updated)
- Convenience Kit Recall: Medical Action Industries Removes Convenience Kits Containing Namic RA Syringes
- Convenience Kit Recall: American Contract Systems Removes Convenience Kits Containing Namic RA Syringes
- Federal Register: Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse
May 6, 2026
- Patient-Matched Guides for Orthopedic Implants
- Disruptions in Availability of Neurosurgical Patties, Sponges, and Strips - Letter to Health Care Providers
- Federal Register: Patient-Matched Guides for Orthopedic Implants - Guidance for Industry and Food and Drug Administration Staff
May 5, 2026
- Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads
- Sizing Catheter Recall: Cook Medical Removes Various Centimeter Sizing Catheters
- CDRH's Experiential Learning Program (ELP)
- Experiential Learning Program (ELP) Areas of Interest
- Federal Register: Medical Devices:Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device
- Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples
- Federal Register: Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals
May 4, 2026
May 1, 2026
- Webinar – Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge
- eSTAR Program (Updated)