Submission of the Human Engineering File to the FDA and Other Regulatory Bodies: Part II

These are the sections we'll cover in this article.

Sec	Contents
1	Conclusion The device has been found to be safe and effective for the intended users, uses and use environments. Brief summary of HFE/UE processes and results that support this conclusion Discussion of residual use-related risk
2	Descriptions of intended device users, uses, use environments, and training Intended user population(s) and meaningful differences in capabilities between multiple user populations that could affect user interactions with the device Intended use and operational contexts of use Use environments and conditions that could affect user interactions with the device     Training intended for users
3	Description of device user interface  Graphical representation of device and its user interface Description of device user interface Device labeling Overview of operational sequence of device and expected user interactions with user interface

With the exception of Section 1 each one of these sections will have a document or document attached to that section. Each section of the narrative document will be a summary of the foundational document or documents attached to that specific section. Make sure that the foundational documents are clearly referenced in each section.

Section Content Analysis

Section 1: Conclusion

This section is an abstract that includes the conclusion of the research program: that the device is "safe and effective" for those intended to use it. I suggest that this section include a brief description of the device at the beginning, its purpose and what medical issues it addresses. For example, if the medical device was a pacemaker, describe what it does, for whom it is intended and what medical issues it addresses. This description should be about one paragraph in length. And the paragraph should end with the "safe and effective" statement and that as to why this conclusion had been reached is briefly listed below in this section. You can add that a full and complete summary follows this section. 

A brief description of the device may well be helpful to the reviewer(s). Although submitted as a complete package that includes a full and detailed description of the device, the package is often split among several reviewers with specific specialties such as human factors. Therefore, the reviewer of the human engineering file may not read or even see the entire submission. Thus a brief description of the device may well provide some welcome context to the reviewer.

The brief summary of human engineering processes can be as simple as a list of steps that were performed. That could include observational studies/contextual analysis, structured interviews of members of the user population and/or subject-matter experts, prototype testing, use-error identification, etc.

Finally, this would be the place to disclose any lingering use-error problems that remain and how they're being addressed. Also, note that these lingering use-error problems have been determined to be low risk: before or after risk mitigations.

Section 2: Descriptions of intended device users, uses, use environments, and training

This section consists of a discussion who would be using the device -- their characteristics, training, education, certification, etc. -- where and how it would be used and the circumstances were it would be used. And finally, a description of the instructions or training that may be required in order to operate the device.

This section will likely be lengthy and comprehensive. Not as lengthy as the foundation document or documents, but it should include a significant portion of what that document(s) contains. You should include enough information to provide the reviewer with a full understanding of who is expected to use the device, how and when it should be used, where it's expected to be used and what positive outcomes would be expected when it is used. And finally what if any are the circumstances such as  the use environment that could how it might be used or effect whether or not it is used correctly.

Your foundational documents will likely include several specific device use scenarios. Include some of the most illustrative of those scenarios in your narrative. 

Devices are often targeted for use by specific classes of users in specific environments. For example, a device may be targeted for use by ICU nurses in the ICU. However, the device could conceivably be used in the general hospital setting by general practice nurses, especially inexperienced or recently graduated nurses. This section should discuss this possibility and what might be needed to be done to adapt the device to other environments and more groups of users with different skills and skill levels.

Finally, summarize the research evidence collected as well as the analysis performed that pertain to this section. Be sure to reference all the foundational documents as well as any internal or outside, published research not specifically performed for this device but applicable to this section. 

Section 3: Description of device user interface 

It may be worth considering lifting the entire description with the images from the foundation document and placing it in the narrative. And then consider what you can remove and still provide the reviewer with adequate information to evaluate the operation of the device. The entire user manual will likely not be necessary to be included in the narrative. You could consider having someone who is not familiar with the device read the description to determine if enough information has been provided. If the person can accurately describe how users would interact with the user interface in order to accomplish specific task (with the images of the user interface that you have provided), then your description is adequate.

Although not stated, this would be an acceptable section to summarize the design process, the evidence that lead to the finalized design and how that evidence was used to both create the initial design and iterate the design until it reached its final form.