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?