Presentation
Navigating Different Human Factors Submissions to FDA: Demystifying Submission Strategies and Requirements Based on Two of the FDA's Most Recent Guidance Documents
SessionPoster Session 2
DescriptionHuman factors (HF) engineering is essential to the safe and effective use of medical devices and combination products, yet determining the level of HF work required for FDA submission can be confusing for manufacturers. Recent FDA guidance provides structured pathways for evaluating when HF activities are necessary and what documentation should be included in a submission. This poster will present a clear, practical framework for understanding these expectations, focusing on how risk-based approaches and the identification of critical tasks guide the HF submission process.
For medical devices, the FDA’s draft guidance on Content of Human Factors Information in Medical Device Marketing Submissions introduces three HF Submission Categories. Depending on whether the device is new or modified, whether user interface (UI) changes are present, and whether those changes impact or introduce critical tasks, manufacturers must provide either a high-level summary, a rationale for limited HF work, or a full HF engineering report including validation testing. For combination products, the FDA’s Application of Human Factors Engineering Principles for Combination Products emphasizes unique considerations such as the interplay of drug and device components, a broader definition of critical tasks, the role of training in HF validation, and how HF data inform clinical investigations.
The poster will illustrate these frameworks side-by-side, highlighting common client questions such as: “Do we need a study?” and “What goes into the submission?” The key takeaway is that HF submissions are not one-size-fits-all, but instead are tailored to product type and risk level. By demystifying the decision process, this poster aims to equip practitioners with a practical lens for planning HF activities, anticipating regulatory expectations, and ensuring that patient safety and device usability remain at the forefront of product development.
For medical devices, the FDA’s draft guidance on Content of Human Factors Information in Medical Device Marketing Submissions introduces three HF Submission Categories. Depending on whether the device is new or modified, whether user interface (UI) changes are present, and whether those changes impact or introduce critical tasks, manufacturers must provide either a high-level summary, a rationale for limited HF work, or a full HF engineering report including validation testing. For combination products, the FDA’s Application of Human Factors Engineering Principles for Combination Products emphasizes unique considerations such as the interplay of drug and device components, a broader definition of critical tasks, the role of training in HF validation, and how HF data inform clinical investigations.
The poster will illustrate these frameworks side-by-side, highlighting common client questions such as: “Do we need a study?” and “What goes into the submission?” The key takeaway is that HF submissions are not one-size-fits-all, but instead are tailored to product type and risk level. By demystifying the decision process, this poster aims to equip practitioners with a practical lens for planning HF activities, anticipating regulatory expectations, and ensuring that patient safety and device usability remain at the forefront of product development.
Event Type
Poster Presentation
TimeTuesday, March 244:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices