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FDA Issues Emergency Use Authorization for Ventilators

Michigan Business Network
March 27, 2020 4:30 PM

The U.S. Food and Drug Administration (FDA) took action to make more ventilators available to health care personnel in the United States.

 The FDA issued an emergency use authorization for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories.
 
Yesterday’s emergency use authorization allows ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories to be used in health care settings during the coronavirus (COVID-19) pandemic.
 
Manufacturers and other stakeholders may submit a request to the FDA under the process outlined in the EUA to have their device(s) added to the EUA.

in2being WILL HOST A WEBINAR ON THIS TOPIC TODAY, MARCH 27TH AT 2:00 PM
 
The webinar will:
  • Cover the details of the Emergency Use Authorization,
  • Feature a discussion with manufacturers, material suppliers and healthcare systems about their efforts and needs
  • Have a Q&A with attendees
REGISTER NOW
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Michigan Business Network is an online broadcasting company that provides knowledge, news, and insights into Michigan’s businesses, industries, and economy.