Human Factors Information Needed in Medical Device Marketing Submissions (DRAFT)
This guidance provides a risk-based framework to determine what human factors (HF) information should be included in medical device marketing submissions to FDA (510(k)s, De Novo requests, PMAs, PMA supplements, and HDE applications). It does not describe how to perform HF evaluations or when a marketing submission is required.
This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What is the purpose of the FDA’s new human factors guidance for medical device submissions?
This guidance provides a risk-based framework to help manufacturers determine what human factors information should be included in marketing submissions. It aims to improve FDA review efficiency by reducing requests for additional information while ensuring device safety.
How do I determine which Human Factors Submission Category applies to my device?
Use the flowchart in Figure 1 to answer three decision points: Is it a modification to an existing device? Are there changes to user interface, users, uses, environments, training, or labeling? Are there critical tasks or impacts to existing critical tasks?
What are critical tasks in the context of human factors engineering?
Critical tasks are user tasks which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm includes compromised medical care. They form the basis for determining submission requirements.
What information is required for HF Submission Category 1 devices?
Category 1 requires only a conclusion and high-level summary of human factors evaluation, plus a statement justifying that device modifications don’t affect human factors considerations. This applies when modifications don’t impact user interface elements.
When is human factors validation testing required in marketing submissions?
Validation testing is required for HF Submission Category 3, which applies to new devices with critical tasks or modified devices where critical tasks are newly introduced or existing critical tasks are impacted by changes.
How does this guidance relate to the existing “Applying Human Factors” guidance?
This new guidance complements the existing 2016 guidance by focusing specifically on submission content rather than the human factors process itself. Upon finalization, it will supersede certain sections of the existing guidance with updated definitions and documentation requirements.
What You Need to Do 👇
Recommended Actions
- Determine appropriate HF Submission Category using the flowchart and decision points
- Conduct use-related risk analysis to identify critical tasks
- Document intended users, uses, and use environments
- Describe device user interface and any modifications
- Analyze and document use-related hazards and risks
- Implement and validate risk mitigation measures
- Prepare appropriate HF documentation based on submission category
- Include rationale for residual risks
- Maintain complete HF documentation in design history file
- Submit required HF information in marketing submission based on category
Key Considerations
Human Factors
- Use a risk-based approach to determine HF Submission Category (1, 2, or 3)
- Identify presence of or modifications to critical tasks
- Provide appropriate level of HF information based on category:
- Category 1: Conclusion and high-level summary
- Category 2: Rationale for no critical tasks
- Category 3: Full HF engineering report with validation testing
Labelling
- Include copies of labeling provided to users
- Document changes to labeling when modifying existing devices
- Describe training materials when applicable
Safety
- Identify and analyze use-related hazards and risks
- Document risk mitigation measures
- Provide rationale for acceptable residual risks
Other considerations
- Describe intended users, uses, and use environments
- Document user interface design and modifications
- Summarize known use problems
- Include preliminary analyses and evaluations when applicable
Relevant Guidances đź”—
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- List of Device Types That Require Human Factors Data in Premarket Submissions (Draft)
- Design Considerations for Medical Devices Intended for Home Use
Related references and norms đź“‚
- ANSI/AAMI/IEC 62366-1:2015+AMD1:2020: Medical devices—Part 1: Application of usability engineering to medical devices
- ANSI/AAMI/ISO 14971:2019: Medical devices—Application of risk management to medical devices
- ANSI/AAMI HE75:2009/(R)2018: Human factors engineering - Design of medical devices