FDA opens the MDUFA V reauthorisation to public comment as the current authority runs to September 2027
FDA held its public meeting on reauthorising the Medical Device User Fee Amendments for FY2028 to FY2032 on 5 August…
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US / FDA updates on medical device regulation and quality.
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26 articles in US
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FDA Appoints Acting Director for Center for Drug Evaluation and Research
The U.S. Food and Drug Administration (FDA) announced the appointment of Tracy Beth Høeg, M.D., Ph.D., as the acting director…
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FDA Issues Early Alert on Glucose Monitor Sensor Risks from Abbott Diabetes Care
The FDA has issued an Early Alert regarding a significant safety concern involving certain glucose monitor sensors manufactured by Abbott…
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Critical Update: Olympus Modifies Use Instructions for Single Use Ligating Device PolyLoop
On December 3, 2025, the FDA announced a significant correction related to Olympus’s Single Use Ligating Device PolyLoop. This update…
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FDA Issues Urgent Recall for SJM Pericardial Patch Due to Quality Control Issue
An urgent recall has been announced for a specific lot of SJM Pericardial Patch devices distributed by Glycar SA. Health…
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FDA Issues Serious Correction Notification for BD Alaris Pump Modules Due to Safety Risks
The United States Food and Drug Administration (FDA) has released an updated correction notification for BD Alaris pump modules. These…
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Critical Recall Alert: Baxter Removes Life2000 Ventilator System Over Cybersecurity Risks
The FDA has announced a Class I recall for Baxter’s Life2000 Ventilation System, citing serious potential risks tied to cybersecurity…
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FDA Issues Urgent Recall of Mega Ballast Medical Devices Due to Serious Health Risks
The FDA has flagged a critical recall concerning Balt USA’s Mega Ballast Distal Access Platform devices, identified as carrying a…
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FDA Issues Critical Recall Alert for Intersurgical i-View Video Laryngoscopes
On November 22, 2025, the FDA released details regarding a significant recall of the i-View Video Laryngoscope, manufactured by Intersurgical…
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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 its NOxBOXi Nitric Oxide…
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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 safety risk that may…
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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, LP. The company is…
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