USA – FDA issues at-home and OTC COVID-19 testing template

Developers of COVID-19 diagnostic tests designed for at-home and over-the-counter use have a new template they can use to submit emergency use authorization (EUA) requests to the US Food and Drug Administration (FDA).
 
For at-home testing, the template includes recommendations for developers in the scenario where samples are collected, analyzed, and results returned without the sample being sent to a laboratory for analysis. Additional validation recommendations are provided in the template for tests available without a prescription.
 
Providing the template, said FDA, is a step toward having tests available during the pandemic that can be performed entirely outside of a clinical setting; in addition to home-based testing, schools and workplaces may benefit from these types of tests.

“The FDA continues to help facilitate innovation in test development, thereby enhancing Americans’ access to COVID-19 tests,” said FDA Commissioner Stephen M. Hahn, MD. “The recommendations provided today are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test.”…