Emergency Use Authorization: Ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors and ventilator accessories (Mar. 24, 2020)

The record

Jurisdiction

United States (federal); Food and Drug Administration

Level

Federal

Authority

FD&C Act s. 564(c), (d)

Issued

2020-03-24 Mar. 24, 2020

Effective

2020-03-24

End

Through the public health emergency (transition per 88 Fed. Reg. 15417) (read as 2021-09-30)

In force

Mar. 24, 2020 to Sept. 30, 2021

Quarters

2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3

2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3

Limitation types

Health care ordersSupply chain

Addressees

• manufacturers and other stakeholders

Functions reached

• SC supply chain
• PF production floor (automakers and others converted to ventilator production)
• IP inpatient surge capacity

Collection

Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

This Emergency Use Authorization (EUA) is being issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in healthcare settings to treat patients during the Coronavirus Disease 2019 (COVID-19) pandemic.... the scope of this authorization is limited to the use of authorized ventilators, ventilator tubing connectors, and ventilator accessories listed in Appendix B for use in healthcare settings to treat patients during the COVID-19 pandemic

Enforcement

Notes