510(k) for a research purposes


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That is the core question!
Pre-sub is a long and costly process, by way of preparation.


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This is an interesting question :) It's hard to answer without knowing the specifics of the device in question, but here's my 2 cents...

To me, the considerations here are 1) the device is not being used on patients, so that would change the hazards/harm that could result 2) you are limiting the user population to specific trained professionals (presuming that's what "research facility" means here).

This would affect how you do risk management, the labeling you have to provide to the user, and the human factors/usability studies.
Those are the areas where FDA may accept something different for a research only device vs a commercial device. I would think that if the device performance is acceptable for clinical use, FDA would be more okay with the limited user population for a research-use only device.

I think you would have a harder time arguing to support reduced device performance. For example if commercial devices have an accuracy of 95% and you're trying to argue that 85% accuracy is acceptable for a "research use only" device... I think FDA might have a harder time with that. I think you could use a predicate commercial device and restrict the use scenario as long as you meet the same performance requirements.

If you are trying to argue that worse performance is acceptable "for research use" because the intent is to improve the device performance for commercial use, I think that would be more appropriate for an IDE.
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