Today, the U.S. Food and Drug Administration (FDA) took steps to further support the development of COVID-19 tests for at-home self-collection by providing on its website a template that may be used to facilitate submission of requests for emergency use authorizations (EUA) for at-home sample collection kits. As explained in FDA’s guidance, Policy for COVID-19 Tests During the Public Health Emergency (Revised), this template reflects FDA’s current thinking on the data and information that developers should submit to facilitate the EUA process.
In particular, this template includes recommendations for use by laboratories and commercial manufacturers who may choose to use it to facilitate the preparation and submission of an EUA request. Currently, developers can offer a COVID-19 test for at-home self-collection where specifically authorized under an EUA or as part of an Institutional Review Board (IRB)-approved study.
No hay comentarios:
Publicar un comentario