Part 4: FDA Ecmo Bypass Device Guidance | COVID-19


ECMO Bypass Device Guidance

Navigating the Regulatory Pathway during a Global Pandemic

What are the motivations for the COVID-19 ECMO Bypass Devices guidance?

    • COVID-19 can trigger acute respiratory failure and/or acute cardiopulmonary failure.
    • Extracorporeal oxygenation for greater than 6 hours may be essential treatment.
    • Modified Cardiopulmonary bypass (CPB) devices may expand availability of EMCO therapy.

What medical device types are covered by this guidance?

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