Regulatory Affairs

Critical Updates: Field Safety Notices Issued for Medical Devices (11–15 August 2025)

Healthcare professionals, regulatory experts, and clinical teams take note: field safety notices (FSNs) issued between 11 and 15 August 2025…

FDA Signals Urgent Catheter Packaging Defect: Abbott’s Updated Guidance for TactiFlex Ablation Users

The FDA has recently issued an early alert highlighting a critical concern with Abbott’s TactiFlex Ablation Catheter, Sensor Enabled. This…

IMDRF Unveils Affiliate Membership Opportunity for Global Regulatory Authorities

The International Medical Device Regulators Forum (IMDRF) has introduced an important update for medical device regulatory authorities worldwide. The announcement…

FDA Greenlights Expanded Pediatric and Adult Use of Vonvendi for von Willebrand Disease

The U.S. Food and Drug Administration (FDA) has announced its approval for the expanded use of Vonvendi, also known as…

Important Notification: Barcode Error on Fexofenadine Hydrochloride 120mg Tablets by Chanelle Medical

The Medicines and Healthcare products Regulatory Agency (MHRA) has been notified about a barcode error affecting specific batches of Fexofenadine…

Voluntary Recall Issued for Olympus ViziShot 2 FLEX 19G Needles Due to Safety Concerns

Olympus Corporation has announced a voluntary global recall of specific lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles. These…

Regulatory Updates from the 23rd IMDRF Management Committee Meeting in Brussels

The 23rd Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) took place in Brussels, Belgium, from March…

FDA Targets Misleading Drug Ads with New Compliance Initiative

The U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) have announced major regulatory…

FDA Highlights Safety Alert for Abiomed’s Impella Controllers Due to Purge Retainer Issue

The FDA has issued an early alert regarding a significant safety concern with Abiomed’s Automated Impella Controllers. Clinical, quality, and…

Critical Updates: Field Safety Notices for Medical Devices Issued from 5 to 9 May 2025

Medical device users and healthcare teams should note the publication of new Field Safety Notices (FSNs) from 5 to 9…

FDA Launches Guidance to Advance Non-Opioid Chronic Pain Solutions and Battle Opioid Misuse

The U.S. Food and Drug Administration (FDA) has announced a major step in addressing the opioid crisis by releasing draft…

Key Learnings from the 23rd IMDRF Workshop: Enhancing Post-Market Surveillance in Medical Device Regulation

On September 30, 2025, the International Medical Device Regulators Forum (IMDRF), together with DITTA and GMTA, published key findings from…