OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.) – For Use with whole Blood – July 31, 2015 On July 31, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa…
Medical Device Bans
Medical Device Safety: Get e-mail updates What is a Medical Device Ban? A medical device ban is a total prohibition on the current and future sales, distribution, and manufacturing of a medical device. The FDA has the authority to ban a medical device intended for human use if it finds, on the basis of all…
Webcast Archive and Presentations posted for Public Workshop
The Food and Drug Administration (FDA) announced the following public workshop entitled “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.” The purpose of this workshop was to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR)…
24 Hour Summary posted for March 16, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
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Class I Medical Device Recall: Verathon Inc. Recalls GlideScope Titanium Single-Use Video Laryngoscope Due to Potential Video Feed Disruption
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Class I Medical Device Recall: Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue
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FDA Presentation posted for March 16, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
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Presentations and Survey Link added to Public Workshop
This workshop aimed to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for Traumatic Brain Injury (TBI). By convening the relevant stakeholders, the goal was to obtain input on the scientific, clinical, patient and regulatory considerations associated with…
Sponsor Presentation and Tesitmonies posted for March 16, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
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