Industry News
The latest medical device regulatory news, clinical trials, and market insights
FDA to Publish Complete Response Letters in Real-Time: New Policy Transforming Regulatory Transparency
The U.S. Food and Drug Administration (FDA) has announced a significant shift in its regulatory communication practices. Starting immediately, the…
Urgent Update: Safety Information Missing in Levetiracetam Accord Oral Solution Documents
Accord Healthcare Limited, UK has formally notified the Medicines and Healthcare products Regulatory Agency (MHRA) of a critical defect related…
FDA Warns Against Imported Cookware Linked to Dangerous Lead Contamination
The U.S. Food and Drug Administration (FDA) has issued a critical update urging both retailers and consumers to stop selling…
FDA Introduces Green List to Prevent Unsafe GLP-1 Drug Imports
The U.S. Food and Drug Administration (FDA) has launched a significant regulatory measure aimed at curbing the entry of illegal…
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…