Medical Device and Pharmaceutical News
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Warning Letter to Zoll Medical for Major QMS Violations
Warning Letter to Zoll Medical for Major QMS Violations The U.S. Food and Drug Administration has issued a Warning Letter to ZOLL Medical Corporation citing significant Quality System Regulation (QSR) violations involving corrective and preventive action (CAPA),...
Abiomed Issues Correction for Automated Impella Controllers
Hardware Updates Required to Address Potential Loss of Hemodynamic Support Abiomed has issued a correction for certain Automated Impella Controllers (AICs) used with the Impella heart pump system after identifying hardware-related issues that could lead to controller...
Infant Formula Recalled after Reports of Botulism
Three Infants Hospitalized; Nationwide Recall Initiated Nara Organics has voluntarily recalled all lots of its powdered infant formula currently on the U.S. market following reports of three cases of infant botulism in infants who reportedly consumed the product. ...
FDA Clears First OTC Continuous Glucose Monitor for Children
Regulatory Snapshot Device: Stelo® Glucose Biosensor System (Dexcom, Inc.)Indication: Continuous glucose monitoring for individuals ages 2 years and older who do not use insulin, including children with diabetes managed through oral medications and individuals seeking...
FDA Early Alert for Baxter Pressure Breathing Device
FDA Issues Early Alert for Baxter Volara System Patient Circuits Following Therapy Leakage Concerns The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue affecting certain Baxter Volara System patient circuits...
FDA Early Alert – Hamilton Medical Breathing Circuit Sets
FDA Issues Early Alert for Hamilton Medical Breathing Circuit Sets Following Reports of Serious Injuries The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding certain Hamilton Medical coaxial breathing circuit sets used with HAMILTON-C1,...
FDA Early Alert for GE HealthCare Infant Resuscitation Systems
FDA Issues Early Alert for GE HealthCare Infant Resuscitation Systems Due to Oxygen Blender Issue Early Alert for GE HealthCare Infant Resuscitation Systems The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue...
Gas Station Drugs: The Regulatory Wild West
Walk into enough gas stations, smoke shops or convenience stores in America and eventually you will encounter a strange modern pharmacy hiding in plain sight. Brightly colored “energy shots.” “Herbal” sexual enhancement pills. Kratom capsules and concentrated...
Warning Letter Cites Serious Deficiencies at Pharma Facility
Serious Sterility and CGMP Deficiencies at ProRx Outsourcing Facility The FDA has issued a significant Warning Letter to ProRx LLC, an FDA-registered outsourcing facility located in Exton, Pennsylvania, citing major violations involving sterile drug compounding...
FDA-Approved Vivistim: A New Pathway in Stroke Recovery
Vivistim implantable vagus nerve stimulator. Source: Vivistim.com.FDA-Approved Vagus Nerve Stimulation Device Opens a New Pathway in Stroke Recovery A company behind one of the world’s most closely watched neurorehabilitation technologies is preparing for a major new...