The Federal Register (FR), in a pre-publication notice today (here), outlined the general process for the authorization and issuance of emergency use authorizations (EUAs) similar to the ones they have been issuing during the COVID-19 pandemic. The FDA is (as are other Agencies of the government) authorized to issue EUAs and are required to publish a listing of each EUA in the FR along with the reason for the need of the EUA. In addition, they must publish a notice when the EUA is rescinded or if the product is otherwise cleared or approved by the Agency such that the EUA is no longer necessary or when the emergency situation has expired.
To conserve resources, the FDA has announced that they will publish consolidated FR notices periodically to inform the public of their actions with regards to EUAs. Today’s notice establishes that process for medical devices.
As the Agency notes:
“COVID-19 related EUAs for medical devices are also currently accessible on the internet from the FDA webpage entitled “Emergency Use Authorizations,” available at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019 .”
Thus, all EUAs for medical devices are available in a timely manner for review once they are issued on the FDA site at the above url.