US FDA EUA Emergency Use Authorization records

[yongqunh]

As seen here:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Copied:
"Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives."

Based on FDA EUA mechanism, FDA provides emergency use authorizations (EUA) for many
High Complexity Molecular-Based Laboratory Developed Tests, like SARS-CoV-2 detection assays.
See: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#LDTs

also:
In Vitro Diagnostic Products
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidinvitrodev

Personal Protective Equipment and Related Devices:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidppe

Ventilators and Other Medical Devices:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidothermeddev

Therapeutics:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidtherapeutics
Detailed Information for all COVID-19 EUAs, including authorizations and fact sheets

The information is quite useful and can be modeled and represented in CIDO.

-- Out of discussion by Asiyah Lin and Oliver He

[linikujp]

Date of FDA EUA authorization needs to be added into the ontology

[yongqunh]

Have we made progress on the representatoin of the FDA EUA authorizations in CIDO?

[linikujp]

In progress for diagnostic tests, but not necessarily for device.
We may not include devices in CIDO due to limitations in man-power resources and lack of use cases. In addition, OBI has included a lot of PPE devices. Although the EUA info are not in OBI PPE devices, all the EUA devices will be a subclasses of an OBI PPE device.