How To Piece Together The EUA Puzzle


 

“An emergency use authorization (EUA) in the United States is an authority granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act added or amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). [1] It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a “material threat” by the Secretary of Homeland Security.[1] Source: Wikipedia

In early 2020, the COVID-19 Pandemic wreaked worldwide carnage on the personal and professional lives of everyone. Many of the basic Personal Protective Equipment that we use every day became scares as the supply chain tightened up globally.

In response, the US Food and Drug Administration has released a multitude of mandates, guidelines and Emergency Use Authorizations since the beginning of the COVID-19 pandemic.

Of particular interest to dentists and other healthcare professionals are the EUA’s that address the uses of face masks such as KN95’s and other PPE.

Below are links a to the more pertinent EUA’s that potentially affect us as dentists and healthcare providers.

To Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators- https://www.fda.gov/media/136664/download

To Manufacturers of Face Masks- https://www.fda.gov/media/137121/download

Appendix A Authorized Respirators (updated May 22, 2020)- https://www.fda.gov/media/136663/download

Respirator Models and Factories Removed from Appendix A as of May 7, 2020 (FDA Blacklist)- https://www.fda.gov/media/137928/download