In addition to being publicly available on the FDA website, this information was routinely conveyed to test developers through pre-EUA interactions, as well as during recurring public virtual town halls.įollowing the EUA request from Lucira Health for their over-the-counter (OTC) COVID-19 & Flu Test, the FDA determined the test posed a risk to consumers due to a toxic substance identified in one of the test components, making it unsuitable for at-home use. The relevant template recommended performing a prospective clinical study and including 50 influenza A positive clinical samples, 30 influenza B positive clinical samples, and 50 SARS-CoV-2 positive clinical samples. The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological HealthĪs part of the FDA’s commitment to address misinformation, we are providing additional information about the agency’s interactions and decisions regarding the emergency use authorization (EUA) of Lucira Health’s COVID-19 & Flu Home test.Īs the standard for EUA is different from the typical, non-emergency, marketing authorization, we made recommendations in publicly available EUA templates to assist developers with the data and information to submit to the FDA in support of a COVID-19 EUA.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |