Regulatory Open Forum

First and foremost, HF/UE studies, as part of risk assessment, are within a risk management process. We need to familiarize ourselves with ISO 14971 and other FDA-recognized standards on Human Factors: IEC 62366, IEC 60601, and AAMI/ANSI HE75. Once you have RM process set in place, a common approach to satisfy both US and EU Submissions HFE/UE Report would contain the following elements:

1. Understand users and use characteristics to define use specification - patients, user, use-environment, etc
2. Assess user interface characteristics related to safety and evaluate known use-related problems – g., Use FEMA
3. Formative Evaluation(s) - expert review, physician feedback, usability test, etc., may require more than one formative evaluations depending on the type of the device
4. Summative Evaluation - validation testing with representative users, use-environment and final design
5. HFE/UE Report - summarize all HF activities, concluding the product is safe and effective, and potential use errors and failures have been eliminated or limited to the extent possible through the application of the HF methods.

There are situations where full-scale human factors or usability engineering process may not be required (e.g., legacy devices or low-risk products), every project is different, the process should be tailored accordingly. Good luck.

First and foremost, HF/UE studies, as part of risk assessment, are within a risk management process. We need to familiarize ourselves with ISO 14971 and other FDA-recognized standards on Human Factors: IEC 62366, IEC 60601, and AAMI/ANSI HE75. Once you have RM process set in place, a common approach to satisfy both US and EU Submissions HFE/UE Report would contain the following elements:

1. Understand users and use characteristics to define use specification - patients, user, use-environment, etc
2. Assess user interface characteristics related to safety and evaluate known use-related problems – g., Use FEMA
3. Formative Evaluation(s) - expert review, physician feedback, usability test, etc., may require more than one formative evaluations depending on the type of the device
4. Summative Evaluation - validation testing with representative users, use-environment and final design
5. HFE/UE Report - summarize all HF activities, concluding the product is safe and effective, and potential use errors and failures have been eliminated or limited to the extent possible through the application of the HF methods.

There are situations where full-scale human factors or usability engineering process may not be required (e.g., legacy devices or low-risk products), every project is different, the process should be tailored accordingly. Good luck.

First and foremost, HF/UE studies, as part of risk assessment, are within a risk management process. We need to familiarize ourselves with ISO 14971 and other FDA-recognized standards on Human Factors: IEC 62366, IEC 60601, and AAMI/ANSI HE75. Once you have RM process set in place, a common approach to satisfy both US and EU Submissions HFE/UE Report would contain the following elements:

1. Understand users and use characteristics to define use specification - patients, user, use-environment, etc
2. Assess user interface characteristics related to safety and evaluate known use-related problems – g., Use FEMA
3. Formative Evaluation(s) - expert review, physician feedback, usability test, etc., may require more than one formative evaluations depending on the type of the device
4. Summative Evaluation - validation testing with representative users, use-environment and final design
5. HFE/UE Report - summarize all HF activities, concluding the product is safe and effective, and potential use errors and failures have been eliminated or limited to the extent possible through the application of the HF methods.

There are situations where full-scale human factors or usability engineering process may not be required (e.g., legacy devices or low-risk products), every project is different, the process should be tailored accordingly. Good luck.

The IEC 62366-1:2015 Usability Engineering File and the FDA HFE/UE Report are different because they serve different purposes.

The Usability Engineering File collects all the documents related to the usability engineering process. You should make your own checklist for your usability engineering process by searching IEC 62366-1:2015 for the phrase "Compliance is checked by". You will get everything that needs to be in file. Then determine how you implemented the usability engineering process. For example, you might have tailored it or you might have a legacy interface with UOUP. Adjust the checklist. Then identify the specific documents required by your implementation. Be mindful of EU-MDR Annex II(4)(d) which requires, "the precise identity of the controlled documents offering evidence of conformity with each harmonized standard, CS, or other method applied to demonstrate conformity with the general safety and performance requirements". The contents of the Usability Engineering File fall under this provision. See the EU-MDR Annex I(5), for example, since it includes use-error.

There is often a question of the residence of the Usability Engineering File. Usability engineering is one of the specific applications of Risk Management. ISO 14971:2007 is a normative reference, but you should implement ISO 14971:2019. Some people like to include the Usability Engineering File in the ISO 14971:2019 Risk Management File. Others keep it as a separate file. In either case, the ISO 14971:2019 Risk Management Plan applies. You will need, at least, the risk acceptability criteria for the case when you cannot estimate the probability of occurrence of harm. You will not be able to estimate the probability of use-error as you analyze the hazard-related use scenarios.

There is often a question of the residence of the Risk Management File and the Usability Engineering File. In an FDA QSR implementation, they are in the Design History File. In an ISO 13485:2016 implementation, they are in the Design and Development File. After release to production certain parts of these files move for maintenance in the Production and Post-production phases.

The FDA HFE/UE Report is just that, a report. It is a document not a file. There are two situations for FDA, whether or not the pre-market submission requires the report. There is a draft guidance document, List of Highest Priorities Devices for Human Factor Review, that answers the question.

In QSR, usability is part of the 820.30(g) design validation because it addresses patient or user needs. If you need to write the report, follow the format in the guidance document Applying Human Factors and Usability Engineering to Medical Devices, Appendix A. Include the report in the DHF. I recommend including it in the Usability Engineering File.