AAHomecare Develops FAQs on Ventilator EUA
The following article is from the AAHomecare Insider 6/08/2022:
In March 2020, the Food & Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to address the insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 Public Health Emergency (PHE).
Leaders on the American Association for Homecare’s Regulatory Council have developed a brief FAQ document that provides an overview on the EUA and includes info on additional resources to help suppliers determine what devices are covered.
Please note that the FAQ document is provided as an informational service by AAHomecare and does not constitute legal advice. We recommend that you consult the FDA and your regulatory counsel if you have additional questions.
- FAQ: FDA Emergency Use Authorization for Ventilators and Other Respiratory Devices
- FDA Ventilators and Ventilator Accessories EUA page
- March 2020 Ventilator EUA