Requirements and Study Designs for U.S. Regulatory Approval of Influenza Home Tests

J Clin Microbiol. 2022 May 18;60(5):e0188421. doi: 10.1128/JCM.01884-21. Epub 2021 Dec 15.


Home testing for infectious disease has come to the forefront during the COVID-19 pandemic. There is now considerable commercial interest in developing complete home tests for a variety of viral and bacterial pathogens. However, the regulatory science around home infectious disease test approval and procedures that test manufacturers and laboratory professionals will need to follow have not yet been formalized by the U.S. Food and Drug Administration (FDA), with the exception of Emergency Use Authorization (EUA) guidance for COVID-19 tests. We describe the state of home-based testing for influenza with a focus on sample-to-result home tests, discuss the various regulatory pathways by which these products can reach populations, and provide recommendations for study designs, patient samples, and other important features necessary to gain market access. These recommendations have potential application for home use tests being developed for other viral respiratory infections, such as COVID-19, as guidance moves from EUA designation into 510(k) requirements.

Keywords: FDA; home test; influenza; regulation; study design.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19* / diagnosis
  • Humans
  • Influenza, Human* / diagnosis
  • Laboratories
  • Pandemics
  • SARS-CoV-2