FDA Emergency Use Authorization (EUA) for COVID-19 test
GPTKB entity
Statements (26)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory authorization
|
| gptkbp:appliesTo |
COVID-19 diagnostic tests
COVID-19 antigen tests COVID-19 molecular tests COVID-19 serology tests |
| gptkbp:awardedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:criteria |
state of emergency
no adequate, approved, and available alternatives known and potential benefits outweigh known and potential risks |
| gptkbp:duration |
valid until emergency declaration ends or authorization is revoked
|
| gptkbp:enables |
rapid deployment of COVID-19 tests
testing in non-traditional settings use of tests prior to full FDA approval |
| gptkbp:firstIssueDate |
February 2020
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Emergency Use Authorization (EUA) for COVID-19 test
|
| gptkbp:legalBasis |
gptkb:Section_564_of_the_Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:monitors |
gptkb:FDA_Center_for_Biologics_Evaluation_and_Research
gptkb:FDA_Center_for_Devices_and_Radiological_Health |
| gptkbp:purpose |
allow use of unapproved medical products during public health emergencies
|
| gptkbp:relatedTo |
gptkb:COVID-19_pandemic
|
| gptkbp:repealedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:requires |
fact sheets for healthcare providers and patients
submission of validation data |
| gptkbp:website |
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
|
| gptkbp:bfsParent |
gptkb:Resolution_Bioscience
|
| gptkbp:bfsLayer |
7
|