Regulatory Affairs

Critical Update: 3M Issues Urgent Labeling Correction for Ranger Blood and Fluid Warming Systems

The 3M Company has announced a critical correction for its Ranger Blood and Fluid Warming Systems, following discrepancies between labeled…

Important Regulatory Notification: Patient Safety Gaps Identified in Ipca Laboratories UK Ltd PILs

On September 30, 2025, Ipca Laboratories UK Ltd issued an urgent notification to the Medicines and Healthcare products Regulatory Agency…

U.S. Agencies Execute Record Seizure of Unauthorized E-Cigarettes Worth $86.5 Million

The U.S. Department of Health and Human Services (HHS) and U.S. Customs and Border Protection (CBP) announced on September 30,…

IMDRF Releases Progress Update on Strategic Plan 2021-2025

The International Medical Device Regulators Forum (IMDRF) has provided a detailed progress report on its Strategic Plan for 2021-2025. Released…

Critical FDA Warning: Olympus Initiates Recall of ViziShot 2 FLEX (19G) Needles Due to Safety Risks

On August 6, 2025, Olympus issued an urgent recall for specific lots of its ViziShot 2 FLEX (19G) Endobronchial Ultrasound…

Critical Updates on Medical Device Field Safety Notices Issued from 18 to 22 August 2025

Between 18 and 22 August 2025, several Field Safety Notices (FSNs) were issued for medical devices, alerting clinicians, regulatory staff,…

FDA Unveils Groundbreaking Dashboard for Real-Time Reporting of Cosmetic Product Adverse Events

On September 30, 2025, the U.S. Food and Drug Administration (FDA) introduced a new interactive tool, the FDA Adverse Event…

Stay Updated on IMDRF Developments: A New Way to Access Alerts

Attention clinical, quality, and regulatory professionals: the International Medical Device Regulators Forum (IMDRF) is making it easier for stakeholders to…

Essential Tools for Tracking Medical Device Recalls and Alerts

On September 30, 2025, the FDA spotlighted the resources designed to help medical device professionals stay informed about recalls, market…

Essential MHRA Updates: August 2025 Safety Guidance for Medicines and Medical Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has released its latest safety advice for August 2025, addressing crucial updates…

FDA Accelerates Approval of Forzinity: A Milestone for Barth Syndrome Treatment

The U.S. Food and Drug Administration (FDA) has taken a groundbreaking step by granting accelerated approval to Forzinity (elamipretide) injection…

Review and Provide Feedback on IMDRF Regulatory Updates from the 24th Management Committee Session

The International Medical Device Regulators Forum (IMDRF) has announced updates from its Working Groups, which are now available for review…