DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1660] Microbiology 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 Administration…
Emergency Use Authorizations: Zika MAC-ELISA (CDC) Updated June 29, 2016
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…
Class I Medical Device Recall: HeartWare Inc. Extends Recall to Include Batteries Used in the Ventricular Assist Device Due to Premature Power Depletion
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN 130051 and DEN150007 added)
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Patient and Consumer Stakeholder Meeting Minutes, May 27, 2016
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Webinar for FDA Final Guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
On Monday, August 8, 2016, the FDA will host a webinar to share information and answer questions about its final guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices. This final guidance, issued on June 21, provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric…
FDA Voice blog: FDA Celebrates the 40th Anniversary of the Medical Device Amendments
By: Jeffrey Shuren, M.D., J.D. In 1976, Steve Jobs and Steve Wozniak founded Apple and a gallon of gas was $.59. And in another action that has had long term impact, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age…
Transcript posted for May 24, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting
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Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
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Emergency Use Authorizations
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…