Part 2: FDA Ventilators & Other Respiratory Devices Guidance | COVID-19

 

Ventilators & Other Respiratory Devices Guidance

Navigating the Regulatory Pathway during a Global Pandemic


What are the motivations for the COVID-19 Ventilators & Other Respiratory Devices guidance?

    • COVID-19 affected patients may develop respiratory failure or respiratory insufficiency;
    • It is necessary to maintain an adequate supply of devices to treat these patients.

What medical device types are covered by the guidance?

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