Emergency Use Authorization: Surgical Masks (umbrella) (issued Aug. 5, 2020; reissued Mar. 6, 2023)

The record

Jurisdiction

United States (federal); Food and Drug Administration

Level

Federal

Authority

FD&C Act s. 564(c), (d), (g)(2)

Issued

2023-03-06 Mar. 6, 2023

Effective

Original authorization Aug. 5, 2020 (read as 2020-08-05)

End

Through the public health emergency (read as 2021-09-30)

In force

Aug. 5, 2020 to Sept. 30, 2021

Quarters

2020 Q32020 Q42021 Q12021 Q22021 Q3

2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3

Limitation types

Health care ordersSupply chain

Addressees

• manufacturers of surgical masks; health care personnel; hospital purchasing departments; authorized distributors and importers

Functions reached

• SC supply chain
• IC infection control

Collection

Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

FDA... issued an Emergency Use Authorization (EUA) for disposable, single-use surgical masks... for use in healthcare settings by healthcare personnel (HCP) as personal protective equipment (PPE) to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic... Since August 5, 2020, FDA has continued to periodically review

Enforcement