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Ex. AGY-FED-HEALTH-OTHER-033 Order Primary source read

Notice, Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 85 Fed. Reg. 27987 (May 12, 2020)

Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability

Food and Drug Administration, HHS · 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. 701(h); 21 C.F.R. 10.115(g)(2)
Issued
2020-05-12 May 12, 2020
Effective
Lists guidances issued Mar. 19-Apr. 2020, each immediately in effect (read as 2020-05-12)
End
Each guidance in effect for the duration of the public health emergency (hand-sanitizer policies withdrawn Dec. 31, 2021; menu labeling to Nov. 7, 2023) (read as 2021-12-31)
In force
May 12, 2020 to Dec. 31, 2021
Quarters
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
Limitation types
Health care ordersSupply chainOther
Addressees
  • manufacturers, distillers, restaurants, food manufacturers, device manufacturers
Functions reached
  • SC supply chain
  • PF production floor (converted lines)
  • KT kitchen and food supply
  • DR dining room (menu labeling)
Collection
Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE).... Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (March 2020).... Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency (March 2020). Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency (April 2020). Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (March 19, 2020) (Updated March 27, 2020, and April 15, 2020).

Enforcement

Statement of FDA enforcement posture under 21 U.S.C. 331 for each listed policy

Notes

Official Federal Register record of the titles and dates of the FDA COVID-19 policies, including the ventilator and shell-egg policies whose texts FDA has since removed from its site.