Dec 14, 2020
United States
The Association for the Advancement of Medical Instrumentation (AAMI) has published a Consensus Report intended to provide guidance regarding the safety-related aspects to be considered by the medical device manufacturers in the context of the Emergency Use...
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Aug 25, 2020
COVID-19
The Food and Drug Administration (FDA) has issued a special warning describing the risk for patients associated with the protective barrier enclosures without negative pressure used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus...
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Jun 26, 2020
COVID-19
The Food and Drug Administration (FDA) issued guidance to provide recommendations for industry representatives applying for the Emergency Use Authorization (EUA) for decontamination and bioburden reduction systems. The document describes special extraordinary measures...
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Jun 16, 2020
COVID-19
The Food and Drug Administration (FDA or the Agency) issued detailed guidelines dedicated to adverse event reporting rules for medical devices placed on the market under the Emergency Use Authorization (EUA). The EUA is a special regulatory framework implemented by...
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Jun 2, 2020
FDA
The European Commission issued a Question and Answer document in order to provide medical device manufacturers with the information regarding the way the new Manufacturer Incident Report (MIR) Form shall be implemented. New Manufacturer Incident Report Form in Brief...
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