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MRI Safety Posters
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Webinar – Final Guidance on Medical Device Reporting for Manufacturers
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2014 Ebola Virus Emergency Use Authorizations: ReEBOV™ Antigen Rapid Test (Zalgen Labs, LLC)
On February 24, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the ReEBOV™ Antigen Rapid Test for the presumptive detection of Zaire Ebola virus (detected in the West Africa outbreak in 2014), Sudan Ebola virus, and Bundibugyo Ebola virus in fingerstick (capillary) whole blood, venous whole blood, and…
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes
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Presentations and Webcast Links added to Public Workshop
The Food and Drug Administration (FDA) announced the following “CDRH Veteran Amputee Device Workshop.” The purpose of this workshop was to engage all stakeholders involved in the research, development, and marketing of prosthetic limb medical devices used by veteran amputees. A specific goal was to engage veteran amputees who use prosthetic limb medical devices and…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN110011 added)
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24 Hour Summary posted for October 25-26, 2016 Technical Electronic Product Radiation Safety Standards Committee
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN160001 added)
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HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall
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