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Ex. AGY-FED-HEALTH-OTHER-053 Order Primary source read

Emergency Use Authorization: Face Shields (umbrella) (issued Apr. 9, 2020; amended Apr. 13, 2020)

Letter of Authorization, Face Shields (Apr. 13, 2020)

Denise M. Hinton, Chief Scientist, FDA · United States (federal); Food and Drug Administration (Federal)

The COVID Project

The record

Jurisdiction
United States (federal); Food and Drug Administration
Level
Federal
Authority
FD&C Act s. 564(c), (d)
Issued
2020-04-13 Apr. 13, 2020
Effective
2020-04-09
End
Through the public health emergency (read as 2021-09-30)
In force
Apr. 9, 2020 to Sept. 30, 2021
Quarters
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
Limitation types
Health care ordersSupply chain
Addressees
  • manufacturers of face shields; health care personnel; hospital purchasing departments and distributors
Functions reached
  • SC supply chain
  • PF production floor (converted plastics and printing firms)
Collection
Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

On April 9, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) in response to concerns relating to insufficient supply and availability of face shields for use by health care personnel (HCP) as personal protective equipment (PPE) in healthcare settings... I am authorizing the emergency use of certain face shields for use by HCP as PPE in health care settings in accordance with CDC recommendations

Enforcement

Conditions of authorization