FDA Issues New Policy on Devices for ECMO Therapy During COVID-19

Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance that allows manufacturers of certain FDA-cleared or FDA-approved extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices to expand device indications or modify designs to increase device availability and facilitate long-term ECMO therapy.  Certain cardiopulmonary bypass devices used to pump blood or oxygenate blood can be used for longer periods of time than currently indicated and may help address urgent public health concerns by expanding the availability of devices to provide ECMO therapy for patients experiencing acute respiratory failure and/or acute cardiopulmonary failure.  This policy reflects FDA's commitment to ease burdens on health care providers and facilities as they face COVID-19.

Read the Guidance Questions? If you have questions about this guidance, contact the Division of Industry and Consumer Education.