How the recently released FDA Human Factors Guidance affected us.
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How the recently released FDA Human Factors Guidance affected us.
Introduction
Implementing a revised US FDA Guidance into the QMS should be easy, right? And it is, but often we gloss over the number of updates that need to be performed. To be current and working to what is expected by the US Food and Drug Administration (FDA), we have to implement these updates.
We recently focused on the revised US FDA Guidance on Human Factors and Usability Engineering for Medical Devices from August 2026.
Our insights
Whilst many of us are being told the differences between the draft guidance (from 2016) and the recently published Guidance, part of my role is to assess the impact of the changes, internally and externally for THAY Medical. What is affected by something that has spent ten years in draft format? The list I wrote started like this:
- Our internal Standard Operating Procedures for Human Factors and Usability Engineering.
- Our document templates for performing Human Factors and Usability Engineering in the USA.
- Our quotations that are with clients already, and those in process for all parts of the Human Factors Engineering process.
- Our team: as consultants, we have to know the guidances inside and out. This means internal training - urgently!
- Updating compliance requirements in the middle of our current projects that involve a USA-focus. Especially the forthcoming Formative Usability Studies and Human Factors Validation Tests.
- Updating documents that cite the draft guidance which are pre-submission from current and past projects.
- Updating our external-focusing documentation (Sales brochures, websites, exhibition stands etc).
And more.
So, even though these are straight-forward changes, the impact is significant in the short term.
Conclusion
In summary, it is not always about knowledge (there are many posts on the internet about this recently published guidance and what the changes are), but the question we have to ask more deeply is "how does this affect my team, my company, our developments and my work?" And this is something every manager, director or project manager has to understand since it can significantly affect time, money and resource.
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Who wrote this insight?
Our Author today was: Greg Thay, Founder, Principal Human Factors Consultant.
Greg is our founder and principal - leading THAY Medical with thirty years of experience in medical devices, pharmaceutical and diagnostic products and AI. Greg has a passion for quality in healthcare. His strong belief is that we are all end-users of medical products and that we should all have the highest standards of looking after each other, regardless what we do in life individually. This belief leads Greg to focus the THAY Medical team to deliver each collaboration time after time, exceeding expectations and assisting to develop cutting-edge, innovative and usable medical products. Often the most successful products are the most usable ones!
If you want to discuss this blog post, please reach out to Greg below - I am sure he would love to hear from you!
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