What Does The FDA’S Emergency Use Authorization (EUA) Mean?
On March 28th, the FDA saw that due to the current situation, there was a shortage of N95 masks. Many hospitals and healthcare workers were unable to find N95 masks and needed direction on what to do.The FDA released a list of approved alternatives for healthcare workers on the frontline. After the initial list was established, they allowed manufacturers to apply for their masks to be added onto the list. Slowly the list grew from about 15 manufacturers to over 70.
On May 7th, the FDA then reduced this list by removing 57 of the approved manufacturers – more or less going back to the same list of manufacturers that were on the initial list of about 15 manufacturers. Manufacturers are increasing capacity and a smaller list is easier for the FDA to monitor.This change was made with healthcare workers on the frontline in mind.The manufacturer’s that were removed are still registered with the FDA as medical device manufacturers.Their medical device listings have not changed.The FDA is simply asking healthcare workers on the frontline to use masks from a more limited list.
We Are Here To Help
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