News wire

Drugs and medical devices

Pharmaceuticals, implants and medical devices: safety communications, label changes, approvals and the litigation that follows them.

Checked 1 min ago · 81 of 90 sources responding · Sources and method

Filter stories (1)
Lawsuits and filings 100Bar and practice news 84Recalls and safety alerts 83Courts and rules 49Regulation and rulemaking 43Mass torts and MDLs 40Drugs and medical devices 32Trucking and commercial vehicles 27Product liability 17Verdicts and settlements 17

Drugs and medical devices

Federal Register notice Federal Register: FDA

Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature

The Food and Drug Administration (FDA) is classifying the flushing and storage solution for vascular autografts at room temperature into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the flushing and storage solution for vascular autografts at room temperature. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also…

AgencyU.S. Food and Drug AdministrationDrugs and medical devices

Read at Federal Register: FDA

Safety notice U.S. Food and Drug Administration (Press releases)

Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions

A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.

AgencyU.S. Food and Drug AdministrationDrugs and medical devices

Read at U.S. Food and Drug Administration (Press releases)

Federal Register notice Federal Register: FDA

Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices

The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer- aided detection and/or diagnosis devices and computer-aided triage and notification devices that was the subject of a notice published in the Federal Register of December 29, 2025. That notice announced FDA's receipt of a petition that requested exemption from the premarket notification requirements for the following generic device types when certain conditions described in the petition were met…

AgencyU.S. Food and Drug AdministrationDrugs and medical devicesRegulation and rulemaking

Read at Federal Register: FDA

Federal Register notice Federal Register: FDA

Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software

The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cardiovascular machine learning- based notification software. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access…

AgencyU.S. Food and Drug AdministrationDrugs and medical devices

Read at Federal Register: FDA

Federal Register notice Federal Register: FDA

Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery

The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cooperative powered surgical assist device for ENT surgery. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also…

AgencyU.S. Food and Drug AdministrationDrugs and medical devices

Read at Federal Register: FDA

Federal Register notice Federal Register: FDA

Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures

The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the temperature regulation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the…

AgencyU.S. Food and Drug AdministrationDrugs and medical devices

Read at Federal Register: FDA

Federal Register notice Federal Register: FDA

Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device

The Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the implanted tibial electrical urinary continence device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial…

AgencyU.S. Food and Drug AdministrationDrugs and medical devices

Read at Federal Register: FDA

Federal Register notice Federal Register: FDA

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease

The Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of…

AgencyU.S. Food and Drug AdministrationDrugs and medical devices

Read at Federal Register: FDA

Federal Register notice Federal Register: FDA

Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access

The Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the extravascular support for an arteriovenous fistula for vascular access. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also…

AgencyU.S. Food and Drug AdministrationDrugs and medical devices

Read at Federal Register: FDA

Federal Register notice Federal Register: FDA

Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System

The Food and Drug Administration (FDA) is classifying the vaginal hydrogel packing system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the vaginal hydrogel packing system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing…

AgencyU.S. Food and Drug AdministrationDrugs and medical devices

Read at Federal Register: FDA