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

In this article we cover section 4 of how to file the human engineering file to the FDA:

4	Summary of known use problems  Known use problems with previous models of the subject device Known use problems with similar devices, predicate devices or devices with similar user interface elements Design modifications implemented in response to  post-market use error problems

Section 4: Summary of known use problems

First, if this device is an update and replacement for an earlier version of the same device, summarize by category (if appropriate) the use related problems that have been detected. These will likely be problems reported from users in the field. This section of the narrative should reference field reports or summaries that should be included with this submission to your approving regulatory body. All problems need not be included in the summary, but be sure that your summary discloses the most concerning and potentially harmful problems that the new release of your device corrects -- and point this out. The narrative need not include specifics on how the use problems of the previous version have been corrected, but be sure to include references to the documentation included with the submission where this is described.

Second, the device being submitted for approval may well be one of many functionally identical or nearly identical devices. In the narrative identify any significant problems found in any of these devices. Be sure to mention how your device avoids or overcomes any of the significant known problems of other devices. This is particularly important if your device is your first version of this type of device. If your device is the first of its kind, then consider referencing devices with similar characteristics including ones your company has created. And address any field detected use related problems and how they have been addressed in the design of the device being submitted for approval.

Collecting information about competitors devices can be a long process. However, most companies I know have people who do competitive market analysis. I have found that much of the information related to other companies products including many issues and concerns has been collected and cataloged by competitive market analysts. Furthermore, information from competitive market analysts can often be an input to the user interface design process. Finally, if the device being submitted for approval has solved many if not most of the user interface issues found in other's devices, that's a competitive edge and something that marketing should want to know about and share with customers and potential customers.

The one issue of concern will be how much overlap should there be between the foundation documentation and the summary included in the narrative. Since the narrative is a summary and a guide for the reviewer, it may be acceptable to have this summary be found only in the narrative. Or the narrative could include a brief summary and a pointer to the foundation document or documents. There is no set rule in this matter. Whatever you chose, you will need to make clear to your reviewer the path you have chosen to take to make this information available.