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# At-Home Tests to Advance Due to Covid Experience: FDA
- URL: https://www.fdaweb.com/at-home-tests-to-advance-due-to-covid-experience-fda/
- Published: 2021-03-26T12:00:00.000Z
- Updated: 2026-09-14T16:52:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148982

CDRH’s Covid-19 experience with diagnostics will lay the foundation to expand home testing for routine medical care and future outbreaks. Writing in the 3/22 [*Health Affairs Blog*](https://www.healthaffairs.org/do/10.1377/hblog20210318.9094/full/?ref=fdaweb.com), CDRH director **Jeff Shuren** and Office of In Vitro Diagnostics and Radiological Health director **Tim Stenzel** say progress in advancing technological solutions related to Covid-19 diagnostics will help accelerate the move to more at-home testing long after the pandemic is over.

“As we noted in the [*New England Journal of Medicine*](https://www.nejm.org/doi/full/10.1056/NEJMp2023830?ref=fdaweb.com), the FDA sought to facilitate Covid-19 test evaluation and authorization through the development and availability of templates, providing [recommendations for validation and streamlined submissions](https://thehill.com/opinion/healthcare/515628-fda-were-constantly-working-on-covid-testing-options?ref=fdaweb.com) for FDA emergency use authorization,” they write. “The development and authorization of Covid-19 \[point-of-care\] and at-home tests has been remarkable; a process that can often take more than a year took only a few months in many cases. We believe that lessons learned from our experiences with Covid-19 could be leveraged to facilitate a large-scale effort for swift, widespread access to accurate and reliable tests for a variety of diseases. They can also inform the response to a future public health emergency.”

The CDRH officials offer recommendations on how to advance diagnostics. For example, they recommend that the federal government invest in developing novel technologies that can be used at the point-of-care and at home and for multiple conditions, including potential advances such as sequencing to provide mutation detection, breath analyzers, and light-based devices as long as they are accurate.  

Shuren and Stenzel also suggest the government be equipped to independently evaluate the ability of non-laboratory providers and consumers to use and interpret the tests to “facilitate validation of and assure confidence in the usability of these products. The learnings from these evaluations can inform future test designs. During a national emergency, this capability could be expanded to independently evaluate the clinical performance of tests for the pathogen regardless of the testing location. Developers often face challenges in obtaining viral material or patient specimens to validate their tests. By centralizing these materials and providing this evaluation for developers, the government can expedite the validation and authorization of tests while increasing confidence in test performance.”