- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19). FDA is committed to providing timely guidance to support response efforts to the COVID-19 pandemic. FDA is issuing this guidance to provide its recommendations and expectations to manufacturers of devices that were issued emergency use authorizations (EUAs) related to COVID-19 to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. FDA believes the policy set forth in this guidance will help FDA and other stakeholders transition to normal operations and processes.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2021-D-1149.