Understanding FDA’s New Guidance Document on Human Factors Information in Medical Device Submissions

Jan 18, 2023 | News |

Human Factors Engineering is a crucial part of ensuring the safety and effectiveness of medical devices. Human factors testing is valuable when designing device/user interfaces. To help manufacturers understand the extent of human factors (HF) information required in medical device submissions, the FDA recently published a new draft guidance, “Content of Human Factors Information in Medical Device Marketing Submissions.”

The guidance helps determine what human factors and usability engineering information should be included in marketing submissions. The FDA proposes three risk categories based on modification of use-related hazards and the presence or modification of critical tasks. Each category requires a different amount of documentation to be included in the submission.

The guidance’s goal is to ensure the efficiency of the FDA review process while verifying the device user interface is designed such that if use errors occur, the harm is eliminated or reduced to the extent possible. The guidance will complement FDA’s final guidance, “Applying Human Factors and Usability Engineering to Medical Devices,” issued in 2016. FDA intends to concurrently revise the 2016 guidance with updated definitions. The revision will come when the final guidance of this draft is complete. This new draft guidance will supersede the 2016 “List of Highest Priority Devices for Human Factors Review” draft guidance.

Determining Risk Category

The risk categories are determined by three questions shown in Figure 1 of the guidance (Flowchart illustrating a risk-based approach to determine the HF Submission Category). Category 1 has the least risk and associated documentation, while Category 3 has the most risk and documentation.

The questions for determining which category is applicable are:

Table 1, below, summarizes the answers to these questions and how those answers are evaluated to identify the appropriate risk-based category.

Table 1 – Determining HF Risk Category

Note:     Critical Task is defined as a user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care.

First, looking at new device submissions, it is straightforward. A new device submission would never fall under Category 1. If the new device does not have critical tasks, it will be Category 2. If a new device does have critical tasks, it will be Category 3.

Next, looking at modified device submissions, it gets a little more complex. If the change to a modified device does not affect the use-related hazards listed, it will be Category 1. If it does affect the use-related hazards listed but does not add or impact the critical tasks, it will be Category 2. If the change affects both the use-related hazards listed and the critical tasks, it will be Category 3.

Documentation Information to Include in Submissions

The guidance also explains what information to include in your device submission, providing a recommended structure of eight different sections. As shown in the table above, the category of risk determines how many of the eight sections need to be included in your market submission.

Below are the eight sections, with a brief description:

  1. Conclusion and High-Level Summary: State whether the device has been adequately designed for intended users, uses, and use environments and if any Human Factors Testing was conducted to support this statement. Provide a high-level summary of the use-related risks, the rationale for conducting assessments, and a summary of all HF processes conducted and analysis of the results.
  1. Description of intended device users, uses, use environments, and training: Include details of the intended user population, intended use, operational context of use, and critical aspects of operation.
  1. Description of device-user interface: Provide a graphical and written representation of the device, user interface, and labeling. If it is a modified device, consider using Table 4 from the guidance to compare the user interfaces of the modified and existing devices.
  1. Summary of known use problems: Describe all known use problems for previous models of the same device or similar devices.
  1. Summary of preliminary analysis and evaluations: Identify all preliminary analysis and evaluation methods used, summarize the key results, describe any modifications made in response, and the key findings that informed the summative validation test protocol.
  1. Analysis of hazards and risks associated with use of the device: Include a use-related risk analysis. Provide rationale if a device change does not merit new validation test data.
  1. Identification and description of critical tasks: Explain the process used to identify critical tasks. List and describe all critical tasks. A separate table should highlight the new critical tasks. Provide rationale if any of those critical tasks do not warrant new HF validation test data to support safe use.
  1. Details of HF validation testing of final design: Summarize all HF validation activities conducted. Have a comprehensive analysis of all use errors and problems that occurred that could result in harm, a description of any design modifications made to the user interface in response to the results, and a benefit-risk discussion. The full test protocol and a sample of all scripts and forms used should be appended.

Conclusion

The guidance document’s risk-based categories make it easy to understand what to include in marketing submissions. The FDA provides questions and flowcharts to determine the risk-based category of medical devices relating to Human Factors. Based on that category, it identifies the sections to include in marketing submissions. The guidance also has examples to further explain the categories and required information. The guidance will ensure efficiency and less time wasted when submitting marketing applications.

It is recommended to have a Pre-Submission meeting with the FDA prior to testing. Pre-Subs are an effective way to ensure the FDA is on the same page with the testing protocol.

Call-to-Action

FDA will be accepting comments on the guidance until March 9th, 2023. You can submit comments here.

The complementary guidance on Human Factors and Usability is located here: “Applying Human Factors and Usability Engineering to Medical Devices.”

Human Factors Engineering and Usability are important steps in getting a device to market safely and effectively. However, meeting all the requirements can be confusing and time-consuming. MEDIcept’s human factors and usability experts can provide the support you need to do it right the first time. Have questions or want to learn more? Visit www.medicept.com or email us at mediceptsales@medicept.com.

References

  1. https://www.fda.gov/media/163694/download
  2. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices

Brian Siroka – Associate Medical Device Consultant