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# New EUA Template for ‘Outside a Lab’ Covid Tests
- URL: https://www.fdaweb.com/new-eua-template-for-outside-a-lab-covid-tests/
- Published: 2020-07-29T12:00:00.000Z
- Updated: 2026-09-14T16:22:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147307

FDA has posted a [new template](https://www.fda.gov/media/140615/download?ref=fdaweb.com) for commercial developers to help them develop and submit emergency use authorization requests for Covid-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab (e.g., offices or schools), and that could be available without a prescription. The template includes recommendations for validation when a sample is to be collected and analyzed, and results are to be returned without the need to send a sample to a lab for analysis, an [FDA notice](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-posts-new-template-home-and-over-counter-diagnostic-tests-use-non?ref=fdaweb.com) says. It also gives recommendations for validating tests that are intended to be made available over-the-counter and without a prescription. Additionally, the template outlines the recommended performance for tests, including sensitivity and specificity.