On September 30, 2025, the U.S. Food and Drug Administration (FDA) introduced a new interactive tool,…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
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…
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…
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…
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…
FDA Expands Early Alert Program for High-Risk Medical Device Recalls
On September 29, 2025, the FDA announced the expansion of its Early Alert program. This initiative…
Medical Device Field Safety Notices: Updates from August 25–29, 2025
Field Safety Notices issued between August 25 and 29, 2025, provide crucial updates for stakeholders involved…
IMDRF’s Safety and Performance Workshop: Key Insights for Regulatory Professionals
The International Medical Device Regulators Forum (IMDRF) held a two-part workshop on September 11 and September…
Critical FDA Advisory: Updated Performance Alerts for BD Alaris Infusion Sets
An updated communication from the FDA highlights significant concerns regarding BD Alaris Infusion Sets’ performance under…