When does the FDA deem something "where appropriate"? 21CFR820.30(g)

rwend07

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#11
With all due respect, that's a slightly strange approach in my opinion.

The only place where risk analysis is mentioned in part 820 is Design Control (820.30). If a device (e.g. most class I devices) is completely exempt from that section, where would the FDA draw the authority from to write you up for not doing it? The FDA s not omnipotent and it does need to answer to the courts. Why would they waste their resources on something that is deemed low-risk (and thus essentially off their radar) in the first place?
We must have a misunderstanding. My point is that I would not do risk analysis with Class 1 devices, for your exact reasoning. I thought on the first page you had said that it was required for all devices. I think we're on the same page here.

I guess a bit of a side question is how can they expect full formal risk analysis when it isn't defined anywhere in the regs except for a sentence here or there? I think risk analysis is good for medium/high risk devices no matter what, but wouldn't you have a solid argument if you didn't have them formally documented for any device? Maybe I'm wasting more time than its worth (if so, just tell me that), this is just all very interesting to me how industry accepted best practice has become a standard that it appears the FDA is mandating without any formal documentation from them.
 
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Ronen E

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#12
I thought on the first page you had said that it was required for all devices.
What I wrote up there was:

I would assume that risk analysis is always appropriate, unless you have a rather obvious or overwhelming reason why it's irrelevant, N/A or the like
Being exempt from 820.30 seems to me a rather obvious reason why it would be N/A.
 
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