Category 2 might expose your lifecycle HF problems
By Horacio M Pace-Bedetti, PhD, Principal Human Factors Engineer
Question this answers
What are the challenges of using existing evidence for FDA Category 2 human factors submissions?
Category 2 submissions test whether risk controls remain effective over time. Challenges arise when use-related risk assessments, complaint records, post-market data, and design changes are stored in disconnected systems. Additionally, use errors are often poorly captured or misclassified as technical failures, making it difficult to demonstrate ongoing safety without continuous lifecycle evidence.
One of my favorite messages from the FDA town hall was this: “Human Factors and usability are aspects of a holistic medical device risk management process.”
The more I think about the new HF submission framework, the more I think Category 2 will test exactly that. It is one thing to say that your existing risk controls remain effective. It is another thing to demonstrate it years later when your original URRA sits in one system, complaints somewhere else, post-market information with another team, and design changes in yet another set of documents.
And there is another challenge here. Use-related problems are not always captured particularly well in complaint systems. They can be underreported, poorly described, or simply buried behind what is initially classified as a technical failure. If companies are going to rely more heavily on existing and post-market evidence to support these decisions, they may also need to rethink how they collect and investigate information about actual device use.
This is why I do not see the new guidance as an opportunity to simply do less Human Factors. Yes, it gives companies more flexibility to rely on existing evidence. But that only works when the evidence is accessible, still relevant, and connected to the device you are submitting today.
For some organizations, running another validation study may actually be easier than trying to reconstruct that story from years of disconnected or incomplete records.
To me, this is where lifecycle Human Factors becomes really important. The evidence cannot come together only when a submission is approaching. The URRA, known use problems, post-market signals, design changes and evidence supporting your risk controls need to remain connected throughout the lifecycle.
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