The U.S. Food and Drug Administration has issued an urgent notice regarding the updated instructions for…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Critical Safety Update: NOxBOXi Nitric Oxide Delivery System Correction for Rapid Command Input Issue
NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., has announced a critical correction for…
Attention Clinicians: NOxBOX Ltd. Issues Critical Update for NOxBOXi Nitric Oxide Delivery System Over Dosing Concerns
NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., has issued a vital correction for…
Precautionary Recall of Fingolimod SUN 0.5mg by Sun Pharma: Capsule Breakage Risk Emerges
Sun Pharma UK Limited has issued a precautionary recall for one batch of Fingolimod SUN 0.5…
Feedback Requested: Consultation on SaMD ‘Predetermined Change Control Plans’ Closing December 2025
The Software as a Medical Device (SaMD) Working Group has invited stakeholders to review and comment…
Siemens Healthineers Corrects Critical Safety Issue with 3 Tesla MRI Systems
Siemens Healthineers has announced corrective actions for its 3 Tesla MRI systems, addressing a potentially severe…
Critical FDA Alert: Sterile Medline Convenience Kits Recalled Due to Non-Sterilization
Healthcare professionals and supply managers, please be aware of an urgent recall announced by Medline Industries,…
FDA Launches New Program to Accelerate Meeting Minutes Clarifications
The U.S. Food and Drug Administration (FDA) has introduced a new pilot program aimed at enhancing…
Temporary Approval Issued for Selectol 200 mg Tablets in French Packaging
Swissmedic has issued a temporary authorization allowing the distribution of Selectol 200 mg film-coated tablets in…
Swissmedic Updates: New Measures to Address Suicide Risk with Finasteride and Dutasteride
On November 18, 2025, Swissmedic announced new measures to mitigate the risk of suicidal thoughts associated…