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

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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Why does the FDA seem to be using the 2022 draft guidance already?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?

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

markschnittker

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

AustinBenson-zl

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.

jjmalm

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