Mastering the Pre-Submission Strategy: What to Ask (and Never Ask) the FDA About Human Factors

The Art of the Specific Question for FDA Pre-Submission Guidance and Human Factors  

FDA pre-submission meetings (aka Q-Sub meetings) represent precious opportunities for regulatory guidance, but vague questions yield vague answers that provide little actionable direction. To make the most of the opportunity, innovators should arrive armed with specific positions and detailed rationales rather than open-ended requests for general advice especially regarding human factors. The key is presenting your FDA human factors analysis and risk assessment during pre-submission meetings, then asking for their agreement or disagreement with your specific conclusions. This approach forces regulators to provide binary responses rather than ambiguous guidance that leaves companies guessing about compliance requirements and potentially high cost, or avoidable, next steps. 

Successful FDA human factors strategies and pre-submission meetings require careful preparation across multiple domains. Companies need well-considered user group prioritization with a clear rationale for any proposed combinations or exclusions. Critical FDA human factors task identification must demonstrate deep understanding of actual device operation rather than theoretical use cases. Perhaps most importantly, companies must present clear positions on how FDA human factors validation applies to their device and why the representatives believe that to be true.  

"The FDA is not going to do your human factors homework for you,” Veranex Executive Director, Quality and Regulatory, Naghmeh Nouri, warns. “The agency expects companies to have done their homework and formed educated opinions, especially including user groups and critical tasks, not to seek basic guidance on fundamental HF principles.” 

You may not have all the answers, but FDA pre submission meetings including human factors should affirm whether or not your line of thinking is sound. 

The Biggest Mistake Innovators Make Regarding FDA Human Factors Evaluation in Pre-Submission Meetings 

Putting it mildly, the FDA frowns upon innovators who essentially ask the regulators to do their human factors analytical work for them. Questions like "Do we need human factors studies?" without accompanying analysis and rationale typically receive non-committal responses. Similarly, asking for general guidance on study design without presenting specific protocols and user scenarios wastes valuable meeting time. Companies should never ask questions they haven't thoroughly researched internally first. Instead, present your analysis and ask for validation of your approach. Remember that FDA responses take 45-90 days regardless of question complexity, so make every inquiry count toward advancing your regulatory strategy. 

Be Specific and Seek Binary Answers on FDA Human Factors Evaluation in Pre-Submission Meetings 

Veranex Director of Human Factors Nick Benedetto stated that innovators seeking FDA pre-submission guidance and/or preparing for FDA pre-submission meetings would be wise to include the following in their questions to ask regarding human factors evaluation, engineering and testing:  

• Is our human factors requirement analysis and associated logic sound? 
• Does FDA believe we have appropriately identified critical tasks based on our risk management procedure? 
• Are the characteristics and demographics appropriate as we have defined them? 
• Is the chosen surrogate user group appropriate for the targeted user group? 
• Is the stated simulated use environment representative enough of the actual use? (This goes to relevance. A home use product presented for evaluation at a medical conference booth table is not representative of the use environment for a home use device with a television on and dog barking.  

The bullet: if you haven’t done the work to identify and assess your HF risks, you’re flying blind and taking bigger risks than you probably should. Are you currently asking the right questions? Are those questions specific enough to address the right need? And if you later realize HF was a bigger issue than expected, you could face many, many months of delays, additional work and reputation damage or worse. That’s a costly mistake. Let us help you craft the message that drives you forward. 

Don't let FDA Pre-Submission Meetings Become Missed Opportunities that Cost you Months of Delays and Investor Confidence  

Medical device companies (commonly younger companies or early startups) that have had less interaction with FDA may not appreciate the timing and type of interaction needed for effective interaction with FDA. Compelling, submission-ready human factors analysis that demonstrates deep regulatory understanding is required; not homework requests that signal inexperience to regulatory bodies. Veranex's 25+ years of specialized human factors expertise ensures you arrive at FDA pre-submission meetings with the specific positions and detailed rationales that regulators expect to see. Our integrated teams have guided hundreds of successful regulatory submissions across diverse therapeutic areas, transforming complex user needs and risk assessments into clear, defensible strategies that accelerate your path from concept to market launch.  

Ready to Craft the FDA Human Factors Strategy that Drives your Innovation Forward Instead of Flying Blind?  

Partner with Veranex's proven human factors experts who understand exactly what questions to ask, how to present your analysis, and how to secure the binary regulatory answers that keep your timeline and budget on track.  

Contact us today to discover how our approach and comprehensive human factors and regulatory teams’ expertise can turn your next FDA pre-submission meeting into a competitive advantage.