Emergency Use Authorization: Battelle Critical Care Decontamination System for decontaminating compatible N95 respirators (issued Mar. 28, 2020; reissued Jan. 21, 2021; revoked June 30, 2021)

The record

Jurisdiction

United States (federal); Food and Drug Administration

Level

Federal

Authority

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

Issued

2021-01-21 Jan. 21, 2021

Effective

Original authorization Mar. 28, 2020 (read as 2020-03-28)

End

2021-06-30 (revocation) (read as 2021-06-30)

In force

Mar. 28, 2020 to June 30, 2021

Quarters

2020 Q22020 Q32020 Q42021 Q12021 Q2

2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3

Limitation types

Health care ordersSupply chain

Addressees

• Battelle Memorial Institute; health care facilities

Functions reached

• SC supply chain (PPE reuse)
• IC infection control

Collection

Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

On March 28, 2020, based on your request, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the emergency use of the Battelle CCDS Critical Care Decontamination System... for use in decontaminating compatible N95 respirators for reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of FFRs resulting from the COVID-19 pandemic

Enforcement

Notes