FDA proposes framework for human factors information in device submissions

Regulatory NewsRegulatory News | 12 December 2022 |  By 

The US Food and Drug Administration (FDA) last week issued draft guidance outlining a risk-based framework about what human factors information should be included in marketing submissions for medical devices.
The framework explores how to determine the human factors submission category and what to include in a marketing submission based on that category. Including appropriate human factors information in the marketing submission can improve the efficiency of the agency review by reducing the number of requests for additional information, according to the draft guidance.
“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harm or degrade medical treatment are either eliminated or reduced to the extent possible,” the agency wrote in the draft guidance. “The main factors to consider in a risk-based approach to human factors assessment, as described in this draft guidance, include the identification of (i.e., presence of or modification to) critical tasks and the elimination or reduction of use-related hazards.”
The draft guidance, published on 9 December 2022, revises draft guidance issued in February 2016 called “List of Highest Priority Devices for Human Factors Review.” Once finalized, the new draft guidance is intended to complement the agency’s “Applying Human Factors and Usability Engineering to Medical Devices” guidance. The agency plans to revise that final guidance concurrently based on public comments to the draft guidance document and updates to human factors definitions and documentation. (RELATED: Human Factors Review: FDA Outlines Highest Priority Devices, Regulatory Focus 2 February 2016)
Submission Categories
The draft guidance includes a flowchart, with questions at various decision points, to help manufacturers choose an appropriate submission category. The flowchart is based on the indications for use and the use-related risk analysis, as well as whether the submission is for a new device or a device that already has marketing authorization.
For example, a modification to an existing device that does not include changes to the user interface, intended device users or uses, intended use environment, training or labeling would fall into Human Factors Submission Category 1. Category 2 would apply to new devices with no critical tasks, as well as modified devices that had a change to the user interface, but in which no new critical tasks were introduced and no existing critical tasks were impacted. Category 3, on the other hand, would apply to new devices with critical tasks and modified devices with newly introduced critical tasks and existing critical tasks that were impacted by changes.
What to include
The draft guidance also contains descriptions of the types of human factors information that can be included in the device marketing submission, including:
  • Section 1: Conclusion and high-level summary
  • Section 2: Descriptions of intended device users, uses, use environments, and training
  • Section 3: Description of device-user interface
  • Section 4: Summary of known use problems
  • Section 5: Summary of preliminary analyses and evaluations
  • Section 6: Analysis of hazards and risks associated with use of the device
  • Section 7: Identification and description of critical tasks
  • Section 8: Details of the human factors validation testing of the final design
However, the minimal information recommended for the marketing submission may not include all of these sections, depending on the submission category for the device. For instance, the draft guidance states that for Category 1, manufacturers may include only a conclusion and high-level summary of the human factors evaluation (Section 1).
Category 2 submissions should include Sections 1-4, including a rationale for why there are no critical tasks (new devices only), or no new critical tasks introduced and/or no changes that impact critical tasks (modified devices only).
In Category 3, manufacturers should provide information in Sections 1-8, including a human factors engineering report that contains validation testing that applies to critical tasks (new devices only), or new critical tasks introduced, or existing critical tasks impacted by change (modified devices only).
Public comments on the proposed guidance can be submitted to regulations.gov and labeled Docket No. FDA-2015-D-4599. Comments are due by 9 March 2023.
Draft guidance on “Content of Human Factors Information in Medical Device Marketing Submissions”


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