Regulatory considerations for emergency use authorizations of medical products U/s 564 of the federal food drug and cosmetic act, usa

  • Katikala Chudamani Sunandini Department of Pharmaceutical Regulatory Affairs Hindu College of Pharmacy, Amaravathi Road Guntur – 522002, A.P., India
  • Ramaiah Maddi Department of Pharmaceutical Regulatory Affairs Hindu College of Pharmacy, Amaravathi Road Guntur – 522002, A.P., India
    rampharma83@gmail.com

Abstract

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.

Keywords: United States Federal Food Drug and Cosmetic Act, Emergency Use Authorization, Medical product, Section 564

Downloads

Download data is not yet available.

References

1. Grandviewresearch.com. 2021. Healthcare Contract Manufacturing Market Report, 2021-2028. [online] Available at: [Accessed 30 September 2021].
2. Emergo. 2021. USA – Overview of medical device industry and healthcare statistics. [online] Available at: [Accessed 30 September 2021].
3. U.S. Food and Drug Administration. 2021. Classify Your Medical Device. [online] Available at: [Accessed 30 September 2021].
4. U.S. Food and Drug Administration. 2021. Emergency Use Authorization of Medical Products. [online] Available at: [Accessed 30 September 2021].
5. Cumming, C., 2021. FDA Emergency Use Authorization Guide for Medical Products. [online] Mindflow Design. Available at: [Accessed 30 September 2021].
6. U.S. Food and Drug Administration. 2021. What does FDA regulate? [online] Available at: [Accessed 30 September 2021].
7. Astho.org. 2021. Section 564 of the Federal Food, Drug, and Cosmetic Act Fact Sheet | State Public Health | ASTHO. [online] Available at: [Accessed 30 September 2021].
8. Emergo. 2021. US FDA Registration Process for Medical Devices and IVDs. [online] Available at: [Accessed 30 September 2021].
Published
08-10-2021
Statistics
12 Views | 3 Downloads
Citatons
How to Cite
Katikala, C. S., and R. Maddi. “Regulatory Considerations for Emergency Use Authorizations of Medical Products U/S 564 of the Federal Food Drug and Cosmetic Act, Usa”. World Journal of Current Medical and Pharmaceutical Research, Vol. 3, no. 5, Oct. 2021, pp. 116-9, doi:10.37022/wjcmpr.v3i5.192.
Section
Review Articles