Enforcement policy for extracorporeal membrane oxygenation and cardiopulmonary bypass devices during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff
United States. Department of Health and Human Services. issuing body.
United States. Food and Drug Administration. issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality April 2020
The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide a policy to help expand the availability of devices used in extracorporeal membrane oxygenation (ECMO) therapy to address this public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
