On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…
Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices
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Executive Summary posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting
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FDA-Industry MDUFA IV Reauthorization Meeting Minutes, August 15, 2016
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FDA-Industry MDUFA IV Reauthorization Meeting Minutes, July 26, 2016
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Presentation and Transcript added to Webinar – Draft Guidance on Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
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Class I Medical Device Recall: Alere Recalls INRatio® and INRatio2® PT/INR Monitoring System Due to Incorrect Test Results
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Device and Discontinuation of the Product line Alere plans to remove the INRatio® and INRatio®2 PT/INR Monitoring System, which includes the INRatio® or INRatio2® PT/INR Monitor and the…
Syringe Pump Labeling Request Letter
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Syringe Pump Problems with Fluid Flow Continuity at Low Infusion Rates Can Result in Serious Clinical Consequences: FDA Safety Communication
Date Issued: August 25, 2016 Audience: Health care professionals who use or who train users on programmable syringe pumps Health care professionals responsible for maintaining programmable syringe pumps Health care professionals who are responsible for how drugs are mixed for use in programmable syringe pumps Specialties: Nurses, nurse practitioners, certified registered nurse anesthetists, physician assistants,…
Webinar – Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies
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