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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1126] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice, establishment of a public docket; request for comments. SUMMARY:  The Food and Drug…

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…

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The Food and Drug Administration (FDA) announced the following public workshop titled “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.”  The topic discussed was the appropriate level of Good Manufacturing Practices (GMPs) regulation to ensure the safety and effectiveness of air-conduction hearing aid devices. Date, Time and Location Federal Register Notice Agenda Webcast Archive Registration  Contact…

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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injury or death. Recalled Product: Fetch 2 Aspiration Catheter Model number: 109400-001 Lot numbers: See list below Manufacturing dates: June 11, 2014 to February 19, 2016 Distribution dates: June 24, 2014 to…

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