The Food and Drug Administration (FDA) is announcing a public workshop entitled “Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests.” The purpose of this workshop is to obtain feedback on possible analytical standards and approaches to develop or build on existing standardization efforts in order to optimize FDA’s…
Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants”. The purpose of this workshop is to obtain feedback on ways in which FDA can use curated databases containing information about human genetic variation as sources of valid clinical evidence for…
FDA Voice blog – OpenFDA Makes Medical Device
By: Taha Kass-Hout, M.D., M.S., Roselie A. Bright, Sc.D., M.S., P.M.P. and Ann Ferriter Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of FDA’s Office of Health Informatics, Office of the Chief Scientist OpenFDA is releasing information on medical devices that could spur innovation and advance scientific research. OpenFDA’s Application Programming Interface…
Class I Medical Device Recall: Covidien, Puritan Bennett 980 Ventilators
Recall Class: Class I Date Recall Initiated: July 16, 2015 Device: Puritan Bennett 980 Ventilator System Lot numbers: All lots with the products codes below are affected Manufactured from: March 2014 to June 2015 Distributed from: March 1, 2014 to June 17, 2015 Devices Recalled in the U.S.: 657 Product Codes: 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS,…
Class I Medical Device Recall: Dräger Medical, Evita V500 and Babylog VN500 Ventilators
Recall Class: Class I Date Recall Initiated: July 13, 2015 Device: Evita V500 Ventilator and Babylog VN500 Ventilator Lot numbers: All lots are affected (Catalog Numbers: 8416400, 8417400) Manufactured from: June 1, 2011 to June 30, 2015 Distributed from: June 1, 2011 to June 30, 2015 Devices Recalled in the U.S.: 2,081 Use: The Evita…
Class I Medical Device Recall: CareFusion Alaris Syringe Pump Alarm Error May Cause Interruption of Therapy
Recall Class: Class I Date Recall Initiated: July 2, 2015 Device: Affected Product Codes Alaris Syringe Pump, Model No. 8110 Manufactured from: March 2014 to September 2014 Distributed from: March 17, 2014 to September 30, 2014 Devices Recalled in the U.S.: 6,458 Use: A syringe pump is a small infusion pump that delivers fluids, such…
Class I Medical Device Recall: Elite Biomedical Solutions, Alaris Medley Large Volume Pump (LVP) Frame Membrane, Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump
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Summary Information for: Innova Vascular Self-Expanding Stent System
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Summary Information for: Minerva Endometrial Ablation System
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