Preparing for Human Factors Engineering Meetings with US FDA Checklist

By Andrea Dwyer and Allison Strochlic 

In July 2024, our Human Factors Research & Design team’s Allison Strochlic and Andrea Dwyer delivered a webinar covering Best Practices for Engaging with the US FDA on Human Factors Strategy. They presented actionable advice on making FDA interactions maximally productive and insightful on topics including pre-submitting an human factors (HF) validation test protocol, interpreting and responding to feedback, common topics in focus for FDA’s HF reviews, preparing for and confidently leading FDA meetings on various HF topics, and refining your HF strategy based on the feedback you receive.  

In this article, we summarize our tips for preparing for and participating in meetings with FDA on HF strategy into convenient checklists. Recognizing that most Sponsor-Agency meetings these days are web-based versus in-person at FDA’s headquarters, the below tips focus on virtual meetings. 

Checklist: preparing for the FDA meeting  

• Anticipate receiving written feedback from FDA within 5 days of the pre-scheduled meeting if part of a pre-submission. 

• If you choose to prepare slides, submit them at least 2 business days before the scheduled meeting. 

• Ensure all key stakeholders are aligned on your meeting strategy and content. 

• Invite the right people to the meeting. Generally it’s best to include a multi-disciplinary team (e.g., regulatory, R&D, clinical, quality) and at least one HF expert. 

• Prepare a response for each point you plan to discuss with FDA. Scenario plan and discuss multiple paths to meeting FDA’s requests, including determining internally how much you are willing to negotiate on (and be flexible with the outcome for) each key point. 

• Acknowledge the items for which you are complying with FDA’s exact requests.  

• Identify who will host the meeting overall and who will be the primary and backup speakers to address each topic. 

• Designate someone to take detailed, real-time notes, which will need to be submitted back to FDA for review and finalization. (Note that you may not record the FDA meeting.) 

• Pre-schedule an initial debrief meeting with your team, ideally immediately after the FDA meeting. 

• Update the selected web meeting software (usually, FDA sets up web-based meetings via Zoom) and confirm your company’s firewall does not block access. 

Checklist: during the FDA meeting  

• Arrive 5-10 minutes early. 

• Be prepared to introduce yourself (name, title, and organization you are representing [Sponsor or third-party] only).  

• Speak succinctly and use time wisely. 

• Allow time for discussion on each topic within the allotted meeting duration (usually, 1 hour total). 

• Focus your discussion on HF topics, assuming the meeting is intended to have an HF focus. 

• Have relevant reference documents (e.g., submitted protocols, reports, use-related risk analyses) open and available and be prepared to share your screen. 

Checklist: after the FDA meeting  

• Meet as soon as possible after the FDA meeting in a pre-scheduled debrief meeting. 

• Align internally on meeting content interpretation, initial reactions and next steps. 

• Submit detailed meeting minutes including agreed actions to FDA within 15 days of the meeting. 

• Update documentation and/or conduct additional HF activities based on the method agreed upon with FDA and project team alignment or your best interpretation of the optimal HF strategy based on FDA’s feedback. 

Contact our team to learn more about how we can help you prepare for and participate in HFE meetings with FDA. Or, sign up for a complimentary account with OPUS, the digital platform our team developed to empower companies with HFE training, tools and templates.  

Andrea Dwyer is an Associate Research Director and Allison Strochlic is a Senior Research Director at Emergo by UL.