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# Town Hall Answers Covid Test Questions
- URL: https://www.fdaweb.com/town-hall-answers-covid-test-questions/
- Published: 2021-02-18T12:00:00.000Z
- Updated: 2026-09-14T16:47:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148697

A 2/10 CDRH virtual town hall answered questions about the development and approval of SARS-C0V-2 (Covid-19) diagnostic tests. Office of In Vitro Diagnostics and Radiologic Health director **Timothy Stenzel** and associate director **Toby Lowe** fielded [questions](https://www.fda.gov/media/146012/download?ref=fdaweb.com) on issues including: 

- transferring ownership of an emergency use authorization;
- over-the-counter test waivers;
- a portable Covid breath test;
- FDA review of laboratory-developed Covid tests;
- home-use serology testing;
- the process to validate tests that detect new Covid variants; and
- an EUA holder using a telehealth provider.