Regulatory Open Forum

Recently, I was in a discussion about the requirement for human factor testing for a class 1 510(k) exempt combination product and the guidance in the title of this post was referenced.

What is the community's experience in the incorporation of human factors utilizing this guidance?

My initial thought is that human factors consideration may draw from literature, similar products in the market, etc. rather than conducting costly and time-consuming studies where the drug may be the PMOA.

Does the community believe there is a threshold (ie class 1 510(k) exempt) where human factors may not be necessary because the device is a simplistic or nearly as simplistic as a tongue depressor? 

Recently, I was in a discussion about the requirement for human factor testing for a class 1 510(k) exempt combination product and the guidance in the title of this post was referenced.

What is the community's experience in the incorporation of human factors utilizing this guidance?

My initial thought is that human factors consideration may draw from literature, similar products in the market, etc. rather than conducting costly and time-consuming studies where the drug may be the PMOA.

Does the community believe there is a threshold (ie class 1 510(k) exempt) where human factors may not be necessary because the device is a simplistic or nearly as simplistic as a tongue depressor? 

Human factors is all about refining your design user requirements, aka your design inputs. As such, it is required for all devices, no matter how simple. This means that you should also have data on which to establish those requirements. That said, there are different ways to establish this data, some more burdensome than others. Generally though, you should be wary of literature (for many reasons, not the least of which is that it is very hard to establish they cover the entirety of users and uses). You should also be wary of using "other devices on the market" - using that approach meant that many, many people repeated "human factors problems" like sharps, blunt needle coring, implants with leachable metals etc etc.,

Most good DfSS books describe a number of ways to collect goof usability/human factors inputs. The ISO standard is also worth referencing.

As for the particular guidance document, it has been my experience that rarely, if ever, do ORA personnel reference pre-market guidance when doing inspections. Thus, for a 510(k) exempt device, it seems unlikely that the specific paradigms suggested in that document will ever be referenced. A good device inspector will, however, expect you to have "human factors" design inputs, and a systematic and defensible way of collecting them. Even in the pre-market space, FDA has signaled that they intend to apply it to higher risk devices first.

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Recently, I was in a discussion about the requirement for human factor testing for a class 1 510(k) exempt combination product and the guidance in the title of this post was referenced.

What is the community's experience in the incorporation of human factors utilizing this guidance?

My initial thought is that human factors consideration may draw from literature, similar products in the market, etc. rather than conducting costly and time-consuming studies where the drug may be the PMOA.

Does the community believe there is a threshold (ie class 1 510(k) exempt) where human factors may not be necessary because the device is a simplistic or nearly as simplistic as a tongue depressor? 

Human factors is not a stand alone process, but is tightly integrated into the design and development of a medical device as suggested in the previous comments. While design controls are not a regulatory requirement for Class I US devices (with several exceptions, including devices containing software), design controls are based on good business practices, and if implemented correctly can save time and money (especially post market costs). 

Especially important is the cross-connections between risk management and human factors. While Class I products are deemed "low risk". In fact there are still risks that should be investigated and reduced where indicated. ISO 14971 points out that all medical devices have some degree of risks in the Introduction. These risks include human factors issues that could be caused for example, by a poorly defined user interface. Reducing these risks could reduce complaints and corrective actions that are often costly for the manufacturer. 

Recently, I was in a discussion about the requirement for human factor testing for a class 1 510(k) exempt combination product and the guidance in the title of this post was referenced.

What is the community's experience in the incorporation of human factors utilizing this guidance?

My initial thought is that human factors consideration may draw from literature, similar products in the market, etc. rather than conducting costly and time-consuming studies where the drug may be the PMOA.

Does the community believe there is a threshold (ie class 1 510(k) exempt) where human factors may not be necessary because the device is a simplistic or nearly as simplistic as a tongue depressor?