On December 9, 2022, the U.S. Food & Drug Administration (FDA) released a fresh draft of its HFE guideline manual, entitled Content of Human Factors Information in Medical Device Marketing Submissions. The guidelines are intended to assist medical device manufacturers in deciding what assessment data ought to be included in medical device marketing submissions. The guidelines are outlined in this blog post, along with the submission categories and evaluation data that are required for each category.
The FDA's 2016 final HFE guidance, Applying Human Factors and Usability Engineering to Medical Devices, is meant to be supplemented by the new guidance. The 2016 draft guidance is still very relevant in this situation because the revised guidelines only specify what evaluation data should be included in marketing submissions. Therefore, the reason for the 2016 draft guidance is still referred to as the revised guidelines do not describe how to perform a human factors evaluation.
Choosing the category of the submission and the evaluation data to deliver
Manufacturers can utilize the flowchart in the draft guidance document to establish which of the three designated categories their marketing submission belongs to by responding to the following inquiries:
The three submission categories are described below:
Category 1: Submission must contain a justification on why device alteration “do not affect the human aspects considerations of the changed device” if device that has been modified with no alterations to the user interface, targeted users, device usage, environment usage, training or labelling.
Category 2: Submission must contain justification on why there are no important task (for new device). Meanwhile for altered devices, submission must justify why there are no critical task introduced or disrupted. HFE report (section 1-4) must include together with submission. This submission applied for both new devices without vital job and altered devices without any task addition or adjustment.
Category 3: Submission must include thorough HFE report (section 1-8)0 including all key tasks (for new devices) or new or impacted critical task and result of HF validation tests (for altered devices). Justification also needed if any critical duties were affected (by changing devices) but current risk control mechanism are still sufficient. This submission refers to new devices that perform vital job or alteration on existing devise that affect critical task.
Our suggestion: Any manufacturer pursuing the marketing submission method is advised to first secure the FDA's "buy-in" on the selected submission category.
The FDA has added and updated the HFE report content.
The new advice has update or expand the whole HFE report based on the FDA’s 2016 final HFE guidance. All sections are listed below along with any significant deviations from the 2016 FDA framework and sequence changes on Section 5 and 6.
Section 1: A high-level summary of the use-related risks should now be included in this part, together with an explanation of the HFE procedure that was used (such as HFE studies and evaluations, device-user interface changes, and HF validation testing) and an analysis of the outcomes.
Section 2: Descriptions of the intended audience, applications, working conditions, and training. More instances of "operational context of use" are provided by the FDA, which also explains that it may encompass features of training, device use across clinical applications, setup, maintenance, cleaning, and reprocessing.
Section 3: For device-user interface description, FDA advises to include comparison table for comparison between the proposed alteration for changing devices and the existing device. Meanwhile for written description, the report may include sample table and pictures comparing the original and updated UI component.
Section 4: A list of reported use issues. No significant changes.
Section 5: Synopsis of initial analysis and assessments. No significant changes.
Section 6: For analysis of risks and hazards related to device usage that fall on Category 3 modified device, comparison between original device’s URRA and altered device’s URRA must be attached in report. When a device change alters any job, related damage, and/or risk mitigation measure, the maker should provide an explanation if they decide that fresh HF validation test data is not required.
Section 7: For list of duties and description, manufacturers should prepare a separate table for submission Category 3 that lists any additional important activities and, if appropriate, justifies why the new duties don't require new HF validation testing.
Section 8: Specifics of the final design's HF validation testing. No significant changes.
Implementing the new draft guidelines
According to the new draft guidance, marketing submissions must show that users were taken into account when designing the device and that it is secure and efficient for the intended users, usage, and surroundings. This is in line with the FDA's 2016 final HFE guidance. The new draft guidance's most significant effect is that it is likely to relieve manufacturers of executing specific HFE activities when they have made small changes to marketed devices.
We advise getting FDA approval for the proper submission categories and evaluation data to include. Any queries on the best way to understand and implement the new guidance must be addressed directly with the FDA.
Contact us at info@arqon.com for more information.
Source : US FDA