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Ex. AGY-FED-HEALTH-OTHER-035 Order Primary source read

Notice, Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019, 85 Fed. Reg. 33686 (June 2, 2020)

Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019

Food and Drug Administration, HHS · United States (federal); Food and Drug Administration (Federal)

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The COVID Project

The record

Jurisdiction
United States (federal); Food and Drug Administration
Level
Federal
Authority
FD&C Act s. 564(h)(1)
Issued
2020-06-02 June 2, 2020
Effective
2020-06-02
End
Through the public health emergency (read as 2021-09-30)
In force
June 2, 2020 to Sept. 30, 2021
Quarters
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
Limitation types
Other
Addressees
  • device manufacturers and stakeholders
Functions reached
  • SC supply chain
Collection
Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

On February 4, 2020, under section 564(b)(1) of the FD&C Act, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics... On March 2, 2020... personal respiratory protective devices... On March 24, 2020... medical devices, including alternative products use as medical devices, due to shortages during the COVID-19 outbreak

Enforcement

Procedural

Notes

FDA's own consolidated recital of the three device declarations.

A record of The COVID Project. The instrument's text is the source's; the summary fields are The COVID Project's reading of it. Not legal advice.