FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19

Today, the U.S. Food and Drug Administration (FDA) issued this immediately in effect guidance: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency. The FDA believes the policy set forth in this guidance may help address urgent public health concerns by helping to expand the availability of devices that facilitate respiration, including ventilators and accessories.

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 If you have questions about this draft guidance, contact the Division of Industry and Consumer Education .