How the FDA's COVID-19 EUA Human Factors Requirements May Alter the Industry as We Know It
Event Type
Poster Presentation
TimeThursday, April 152:00pm - 3:00pm EDT
LocationMedical and Drug Delivery Devices
Soon after the COVID-19 public health emergency was declared in the United States, COVID-19 diagnostic product manufacturers quickly began the race to obtain Emergency Use Authorization (EUA). Despite test developers acting swiftly to launch their product to market, the FDA's delay in issuing a clear path to obtaining EUAs and unique usability testing requirements presented many market barriers. Though the FDA actively worked with test developers and answered questions in weekly town halls, like most things in 2020, it was a slow and uncertain process until well into the year. This presentation will provide an understanding of the FDA's unique requirements and thought process for human factors testing for COVID-19 in-vitro diagnostics (IVDs) and explore potential lasting impacts on the agency's human factors enforcement.

Key message:
Though some of the first discussions between the FDA and industry regarding the COVID-19 pandemic were around prevention and testing, the FDA did not officially release detailed guidance on usability testing requirements for COVID-19 IVDs until the serology test template was issued May 4th, 2020. This guidance deviated significantly from past FDA expectations related to human factors. With the release of this template and the additional ones to follow, the industry had its first glimpse at the stark differences in the human factors/usability testing requirements from the FDA 2016 Guidance on Human Factors and Usability Engineering.

One of the most drastic changes were to the sample size requirements: The agency requires a minimum sample size of 15 participants per user group for human factors validation testing for non-EUA medical products; however, many of the COVID-19 IVDs require 100 or more participants to be included in the usability testing. Other notable differences in the FDA's human factors testing recommendations for COVID-19 IVDs which will be discussed include:
• Including Spanish speaking participants and user instructions vs. only English speakers
• Removing the need for healthcare professionals to be observed during usability testing
• Increased focus on quantitative data reporting

This presentation will provide some background on relevant COVID-19 usability testing requirements for the various test types. From there, we will assess the critical differences between the FDA's standard human factors requirements and the new COVID-19 IVD requirements.

Audience Takeaways:
This presentation will provide test developers and medical device manufacturers with a foundational knowledge of the new human factors testing requirements for COVID-19 tests, which may influence the future of the FDA's human factors enforcement. This knowledge will allow the audience to prepare for a potential future shift in the FDA's human factors validation study expectations.