Understanding the FDA’s Human Factors Guidance Draft

On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) issued a new draft guidance, “Content of Human Factors Information in Medical Device Marketing Submissions,” that provides recommendations for the inclusion of human-factors information in marketing submissions.

The drafted guidance is intended to supplement the FDA’s final guidance on Human Factors Evaluation (HFE). Once approved, the draft will replace the existing 2016 guidance.

To help you stay up to date, we’ve dug deep into the new proposed guidance to give you everything you need to know on the FDA’s human-factors guidance draft and what it could mean for your business.

Risk-based approach to gathering HFE information

One overarching theme in the new draft guidance is the agency’s proposal for a risk-based approach to human factors engineering information in marketing submissions.

“The goal of the human factors assessment is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible,” the FDA says in the guidance draft.

However, while human factors are greatly important, the FDA acknowledges that they’re just one component of the agency’s assessments of marketing submissions. “While FDA believes that it is optimal to minimize use-related risks, it may not be necessary, nor practical, to eliminate all use-related device risks,” they say.

The agency calls this risk-based approach the HF Submission Category, and recommends that, at a high level, marketing submissions should serve the following purposes:
• Demonstrate that needs of the intended users were considered in the device design
• Use risk-based analysis to determine categorization
• Prove the device is safe and effective for the intended users, uses, and use environments
• Provide information that explains the presence or absence of critical tasks
• Show validation testing for risk mitigation strategies
• Describe any residual risks

New marketing submission categories proposed

To align with its recommendation for a risk-based approach, the FDA draft proposes three new categories based on the device’s indications for use and the use-related risk analysis.

Category 1 is intended for modifications on an existing device, with no changes to the user interface, intended users, uses, or use environments, training, or labeling.

Category 2 is intended for new devices that don’t have any critical tasks or modifications made to an existing device (including changes to the user interface, intended users, uses, or use environments, training, or labeling) that don’t add or affect critical tasks.

Category 3 is intended for new devices with critical tasks or modifications to an existing device (including changes to the user interface, intended users, uses, or use environments, training, or labeling) that add or affect critical tasks.

As a way of guiding medical device manufacturers in determining the correct HF submission category, the FDA provides a flowchart as well as accompanying tables and explanatory text.

In the HF submission category flowchart, we see three decision points that are accompanied by qualifying questions: 1) Is it a modification to an existing device? 2) Is there a change to any of the following:
• User interface
• Intended device users
• Intended device uses
• Intended use environment(s)
• Training
• Labeling

The third decision point is based on the use-related risk analysis:
• Are there critical tasks? (new devices only)
• Are there new critical tasks introduced, or are existing critical tasks affected? (modified devices only)

New and updated guidelines for human-factors evaluation reports

After arriving at the correct HF submission category, manufacturers can now turn to the final section detailing the required contents of their marketing submission and human-factors evaluation reports.

According to the draft guidance, human-factors evaluation reports would include as many as eight sections:
1. Conclusion and high-level summary
2. Descriptions of intended device users, uses, use environments, and training
3. Description of device-user interface
4. Summary of known use problems
5. Summary of preliminary analyses and evaluations
6. Analysis of hazards and risks associated with use of the device
7. Identification and description of critical tasks
8. Details of the human-factors validation testing of the final design

Depending on which category a device falls under, the human-factors draft guidance establishes which points would need to be included in a human-factors evaluation report.

Category 1 devices only need to include Section 1; Category 2 devices would need to include sections 1–4; and Category 3 devices require all eight sections in the HRE report.

Lastly, the draft guidance outlines the content requirements for each section of the human-factors evaluation report. These sections were previously established in the 2016 guidance, and not all sections have changed in the new draft guidance.

With that in mind, here are the key changes for each section in the FDA’s new human-factors guidance draft.

Section 1

Conclusion and high-level summary. Should now include a high-level summary of the use-related risks, as well as a summary and analysis of the HFE process you’ve used.

Section 2

Descriptions of intended users, uses, use environments, and training. This section expands its examples of operational context of use, including aspects related to training, the device’s clinical applications, setup, maintenance, cleaning, and reprocessing.

Description of device-user interface. If a device is modified, the FDA suggests using a table to compare proposed and existing devices. You’ll also find a new sample table template.

Section 4

Summary of known use problems. No updates or changes.

Section 5

Summary of preliminary analyses and evaluations. No updates or changes.

Section 6

Analysis of hazards and risks associated with the use of the device. For modified devices in Category 3, manufacturers should submit an analysis comparing the modified device’s use-related risk analysis (URRA) to the existing device’s URRA.

Section 7

Identification and description of critical tasks. For submission Category 3, manufacturers would need to generate a table highlighting any new critical tasks and rationale for why new tasks don’t warrant new HF validation testing.

Section 8

Details of the human factors validation testing of the final design. No updates or changes.

Human factors engineering is essential for bringing a high-quality medical device to market because, overall, it’s about providing the best quality management solution for patients under actual conditions of use.

First published Feb. 19, 2023, on the Greenlight Guru Blog. You can read the original article and download a “Human Factors and Usability Engineering Report Template and Checklist” here.

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