The COVID Project
Context, not an orderThis record is guidance or an announcement kept for context. It is not counted among the orders in force.
The record
- Jurisdiction
- United States (federal); Food and Drug Administration, Center for Devices and Radiological Health
- Level
- Federal
- Authority
- FD&C Act ss. 510(k), 513, 519, 520; 21 C.F.R. parts 807, 820, 868; enforcement discretion
- Issued
- 2020-03-22 Mar. 22, 2020
- Effective
- 2020-03-22 (immediately in effect; announced 85 Fed. Reg. 27987) (read as 2020-03-22)
- End
- For the duration of the public health emergency including renewals (transition per 88 Fed. Reg. 15417) (read as 2021-09-30)
- In force
- Mar. 22, 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 chainOther
- Addressees
- manufacturers of ventilators, anesthesia gas machines, CPAP/BiPAP and other respiratory devices; health care facilities
- Functions reached
- PF production floor (manufacturers modifying and converting lines)
- SC supply chain
- IP inpatient surge capacity
- Character
- context
- Collection
- Other federal health agencies AGY-FED-HEALTH-OTHER
Operative words
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.... for the duration of the public health emergency, to help foster the wider availability of devices for patients in need of ventilatory support, FDA does not intend to object to modifications to the FDA-cleared indications, claims, or functionality of these devices, without prior submission of a premarket notification
Enforcement
Enforcement discretion under 21 U.S.C. 331 for the premarket-notification, quality-system and labeling requirements listed
Notes
With the ventilator EUA of Mar. 24, 2020 (Ex. 051), the instrument under which automotive, aerospace and medical-device manufacturers produced and modified ventilators in 2020.
Retrieval noteMarch 24, 2020 archived version of the March 2020 guidance; FDA has since removed the document from its site. Cite it as context and cite the underlying order, statute or emergency rule it describes as the instrument. (Bulletins whose operative text imposes a mandatory duty on licensees under the regulator's own authority are excluded from this downgrade and listed separately for review.)).