Regulatory considerations for emergency use authorizations of medical products U/s 564 of the federal food drug and cosmetic act, usa
The United States (US) remains the greatest medical device (MD) market on earth $156 billion (40 percent of the overall MD market in 2017). By 2023, it is depended upon to create to $208 billion. As per USFDA, the MD are orchestrated into three classifications. The U.S. Food and Drug Administration's and Center for Devices and Radiological Health (CDRH) supervises MD advertised in the United States. The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a group of laws passed by Congress in 1938 offering power to the U.S. Food and Drug organization (FDA) to administer the safety of food, drugs, cosmetic products and MD’s. An Emergency Use Authorization (EUA) under Section 564 of the FD&C Act considers the unique utilization of medications and other clinical products during particular kinds of crises. This review articles focused the process of EUA of medical products u/s 564 of the Federal Food Drug and Cosmetic Act, USA.
2. Emergo. 2021. USA – Overview of medical device industry and healthcare statistics. [online] Available at:
3. U.S. Food and Drug Administration. 2021. Classify Your Medical Device. [online] Available at:
4. U.S. Food and Drug Administration. 2021. Emergency Use Authorization of Medical Products. [online] Available at:
5. Cumming, C., 2021. FDA Emergency Use Authorization Guide for Medical Products. [online] Mindflow Design. Available at:
6. U.S. Food and Drug Administration. 2021. What does FDA regulate? [online] Available at:
7. Astho.org. 2021. Section 564 of the Federal Food, Drug, and Cosmetic Act Fact Sheet | State Public Health | ASTHO. [online] Available at:
8. Emergo. 2021. US FDA Registration Process for Medical Devices and IVDs. [online] Available at:
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