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?

Pages: First |1 | 2 | 3 | ... | Next → | Last