Emergency Use Authorization: NIOSH-approved air purifying respirators for health care personnel (issued Mar. 2, 2020; reissued Mar. 28, 2020 and July 12, 2021)

The record

Jurisdiction

United States (federal); Food and Drug Administration

Level

Federal

Authority

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

Issued

2021-07-12 July 12, 2021

Effective

Original authorization Mar. 2, 2020; reissuance July 12, 2021 removed decontaminated and expired respirators from the scope (read as 2020-03-02)

End

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

In force

Mar. 2, 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

• health care personnel and facilities; CDC

Functions reached

• SC supply chain
• IC infection control

Collection

Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

the FDA determined it is necessary to reissue the March 28, 2020, letter in order to amend the Scope of Authorization (Section II) to remove FFRs that were NIOSH-approved but have since passed the manufacturers' recommended shelf-life and to remove the emergency use authorization of decontaminated respirators from the scope of authorization.... CDC no longer recommends that HCPs use decontaminated or non-NIOSH-approved FFRs

Enforcement

Notes