What’s the difference between FDA human factors requirements and IEC 62366?

The FDA recognizes IEC 62366. Why isn’t that enough for a submission?
Is the difference between “human factors” (HF) vs “usability engineering?” (UE)
Why don’t submission deficiencies match the FDA’s current 2016 guidance?
Why does the FDA seem to be using the 2022 draft guidance already?
Why can’t we use data collected from outside the USA?

[@markschnittker9668]

Wow, really great sharing. Your experience can help a lot of folks avoid making bad assumptions. Thanks for making the video.

[@MedicalDeviceAcademy]

Thanks for watching! The same is true for almost every guidance the FDA has. If there is no guidance, follow the recognized standard (e.g., IEC 60601-1). If there is a guidance (e.g., ISO 10993-1), follow the standard at your peril.

[@user-fv7zd1oc3s]

This is great information. Thank you for making this video.

[@MedicalDeviceAcademy]

Glad it was helpful!

[@jjmalm]

I remember seeing a presentation from a certification lab showing how many incidents are related to use errors. I think it's a big issue the FDA wants to lean on to get the biggest payback for reducing risk. It could well be the safety and efficacy that is shown in a 510k or IDE simply doesn't match the performance in commercial rollout. I can see why, given how arduous it is to cease sales once a 510k or PMA is given the FDA wants a higher certainty the device will perform as claimed by the manufacturer. I know it's frustrating but it's a pretty big "gap" they are seeing. I also think the FDA is at a bit of a loss what to do to reduce recalls and are trying as much as they can to try to get results on the ground, but it's probably not returning the results they hoped for so they are turning up the temperature very hot to try to get a signal.

[@MedicalDeviceAcademy]

You have great points. However, when you look at the FDA data for recalls there are very few recalls where the FDA has identified human factors as the root cause of a recall. It used to be that labeling was #1. Now it's software changes. It has never been human factors. There are many AEs that are related to human factors, but it is not the biggest problem.
I would like to see the FDA release a new guidance and update eSTAR for human factors requirements--just like they did for cybersecurity. It is the only submission requirement that is not well defined in the eSTAR.

[@jjmalm]

@@MedicalDeviceAcademy yeah my premise was based on a presentation from a compliance lab (TÜV I think) that showed a Pareto chart with usability being biggest source of AEs or incidents (maybe). This was over five years ago, so maybe the data are different now