The FDA released last week the final guidance titled Content of Human Factors Information in Medical Device Marketing Submissions. This shows the commitment of the FDA to pursue a rational risk-based framework to guide manufacturers and FDA staff on the human factors (HF) information that should be documented and included in medical device marketing submissions to the Center for Devices and Radiological Health (CDRH).
A key development from this guidance is the creation of three HF submission categories, which hinges first on the introduction (for a new device) or changes (for a follow on submission) to user interface, intended device users, intended device uses, intended use environment(s), training or labeling.
Practically speaking, if either of these questions answers in a yes, then it is at minimum a HF submission category 2, which requires HF information in a conclusion and high-level summary, descriptions of intended device users, uses, use environments, and training, device user interface, summary of known use problems.
The second major hinge is if critical tasks are introduced (in a new or follow on submission) or modified (in a follow on submission). This may result depending on the analysis to perform a full blown HF study (requiring pre-study analyses, use-related risk analysis or URRA and HF validation studies), which is called HF submission category 3.
But if a follow on submission makes no changes per category 2 question or adds / changes critical tasks, then it can be a HF submission category 1 requiring only a conclusion and high-level summary. This reduces the HF documentation requirements dramatically depending on the submission.
Other factors (but not limited to) can impact whether a marketing submission may be a HF submission category 2 or 3, including if:
- There is a significant difference in the subject device compared to similar legally marketed devices that affects its use (e.g., novel technological feature, new indications for use of the device, change in use environment, new user groups).
- New information (e.g., recalls, adverse events, problem reports, complaints) identifies a safety signal for which the cause has been attributed to use error.
- The severity of possible harm resulting from use error has increased.
I think this is a great move by FDA in working with their industry partners, and by no means sets up conditions for reduced safety, as it encourages a more focused view on use related risk when a manufacturer is developing a product. The guidance also gives very clear descriptions in Sections 1-8 for what information would be needed whether a HF submission category 1 (Section 1 recommended), 2 (Sections 1-4 recommended) or 3 (Sections 1-8 plus URRA recommended). This reduces confusion for manufacturers when preparing this information.
Practically speaking, I would advise my clients to perform a URRA in all cases whether preparing a new or follow on marketing submission, regardless if it ultimately fell into HF submission category 1, 2 or 3. A robust URRA effort is key in defining the use related risk factors, but more importantly gives a solid foundation to any assertions that support a HF submission category 1 or category 2 as being adequate. If a HF submission category 3 is identified as necessary, it helps distill the development and better structures the time and resource needed for risk validation studies.
All in all, this is very encouraging step from the FDA and CDRH. This recognizes the reality of resource requirements needed at FDA to review HF validation studies, as well as the resources needed by manufacturers to perform HF validation studies. Giving options on a risk based continuum that is examined thoughtfully gives a lot of value to all parties involved, and focuses HF validation study performance when needed in an even stronger fashion.
I can only hope this is indicative of future guidance releases that would similarly take such a risk-based approach to guide industry in rational documentation development and resource utilization. Key future guidances that come to mind include the proposed “return to draft” guidance for Policy for Device Software Functions and Mobile Medical Applications, as well as the transition from draft to pending final guidance for Artificial Intelligence-Enabled Device Software Functions.
