What The FDA Human Factors Town Hall Means For Medical Device Marketing

Earlier this month, we covered how the FDA’s new human factors guidance makes usability part of the medical device product story. Our core argument is that the same evidence that supports human factors engineering helps marketing and sales teams explain adoption requirements, workflow fit, and the device's practical value.

The much-anticipated FDA’s July 22 town hall reinforced that point, although its primary audience and purpose remained regulatory. The agency used the event to discuss its final guidance on the human factors information manufacturers should include in medical-device marketing submissions. 

The FDA’s Human Factors Guidance does not change how companies conduct the entire human factors engineering and usability engineering process. Instead, it establishes a risk-based framework for deciding what HFE/UE information belongs in a 510(k), De Novo request, PMA, or humanitarian device exemption application. The FDA is not only asking whether a company performed usability work. It wants the submission to present a coherent, supportable explanation of the device-user system, the use-related risks, and the evidence supporting the manufacturer’s conclusions.

The FDA used the town hall to explain how manufacturers should decide what level of human factors documentation to include in a medical-device marketing submission. The required documentation falls into three categories:

• Category 1: A brief conclusion and high-level summary of the human factors evaluation.

• Category 2: A written rationale explaining why new human factors validation testing is not needed.

• Category 3: A full HFE/UE report that includes validation testing for relevant critical tasks.

The town hall also clarified several important points:

1. New critical tasks do not always require new validation testing. Under Decision Point D, manufacturers may rely on existing evidence when the interface has a strong history of safe use, limited complexity, and adequate risk controls.

2. Category 2 still requires substantial support. Companies must explain why existing evidence is sufficient. Simply stating that a device is similar to an earlier product may not be enough.

3. New testing is more likely when risk increases. This includes complex interfaces, known use errors, changes in intended users or use environments, new safety concerns, or a higher potential for harm.

4. The FDA encourages early discussion. Manufacturers can use the Q-Submission Program when they are unsure whether their rationale or testing plan will meet FDA expectations.

5. The transition period is ending. The FDA generally did not expect submissions received before August 1, 2026, to include every element of the new guidance. Companies should now be updating their documentation and review processes.

The Town Hall shows that the FDA’s Human Factors Guidance creates a more formal communications requirement inside the submission. Every conclusion must connect to evidence about:

• Users

• Tasks

• Interfaces

• Use environments

• Training

• Risk controls

The information required sits across several teams. Engineering defines the interface, human factors evaluate use-related risk, and the regulator decides what belongs in the submission. Further, marketing and sales explain the product to buyers and users.

When different teams use different languages, the problem is an evidence-governance issue. For example, marketing may call a device “simple to use” while the HFE/UE report documents significant training requirements. Messaging inconsistency can create problems during regulatory review, promotional review, and commercial launch.

What B2B Medical-Device Marketers Need To Know

Medical-device marketers do not need to become human factors engineers. However, they do need access to the approved findings to understand:

• Who will use the device

• Which tasks are critical

• Where use errors may occur

• What training is required

• Which risk controls are built into the interface

Marketing can use this information to create accurate and regulatory-compliant product messaging, sales materials, and customer education that drives more sales.

Further, with human factors evidence, they can replace vague claims like “intuitive” or “user-friendly” with clear, evidence-based language. Then, your device’s commercial messaging will always match the approved product evidence.

What Medical-Device Companies Should Do Now

Human factors findings should not stay inside the submission. They should guide how your company talks about the device across regulatory, clinical, and commercial teams.

1. Create a shared terminology guide. Define the approved language for:

   
   

   • Intended users

   • Intended uses

   • Use environments

   • Critical tasks

   • Training requirements

   • Risk controls

   
   

   Engineering, quality, and marketing teams should use the same terms.

   
   

2. Connect the evidence to commercial content. Identify where approved human factors findings should inform:

   
   

   • Product messaging

   • Technical explainers

   • Sales training

   • Implementation materials

   • Launch content

   • Customer education

     
     

3. Build review into the process. Marketing should not receive a validation report shortly before launch and decide what can be used. Regulatory, clinical, and commercial teams should review messaging before assets are developed.

   
   

4. Maintain message traceability. Important product statements should connect back to approved evidence, risk documentation, or validated design features. Claims will be easier to review and update when the device, interface, or intended user changes.

Human factors documentation is no longer only a submission requirement. It is part of your product communication system. Borrowed Pen helps medical-device companies turn complex technical evidence into clear, regulatory-aligned content. We develop: 

• Product Messaging Briefs

• Technical Explainers

• Submission-Support Materials

• Sales Enablement Content

• Training Materials

• Internal Messaging Systems

Learn more about our medical-device marketing services and how we help regulatory, technical, and commercial teams communicate from the same evidence.