UDI, Labeling Accessories, General Insanity, Etc.

DitchDigger

DitchDigger

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#1
#1
Let's say hypothetically I found a power cord for a class 1 surgical microscope in the FDA GUDID system. I think to myself... is that really necessary? I know FDA's guidance on medical device accessories is somewhat broad, but unless there's something about this power cord that it's specifically designed and manufactured for use with this device system, it seems a little overkill given FDA's guidance that they don't intend to regulate most COTS-like components as medical device accessories.

Obviously this is all very hypothetical given we don't know what the regulatory files look like for this device, but generally speaking:

  1. Would FDA expect to see a UDI-compliant label on the power cord itself in this case given that it's been uploaded to the GUDID system?
  2. Do most of you think that an accessory like this needs to be uploaded to GUDID and labeled with a UDI?
  3. Is an article a "finished medical device accessory" if it has absolutely no clinical functionality if it's not installed on a medical device, even if it's designed and manufactured specifically for use on a medical device?

I'm in the Class 1 space with a (per IMDRF's definition) configurable medical device system and trying to avoid going crazy with over-labeling components for the configurable system.
 
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Ronen E

Ronen E

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#2
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DitchDigger said:
  1. Would FDA expect to see a UDI-compliant label on the power cord itself in this case given that it's been uploaded to the GUDID system?
Click to expand...
Yes, subject to effective dates.
DitchDigger said:
  1. Do most of you think that an accessory like this needs to be uploaded to GUDID and labeled with a UDI?
Click to expand...
I wouldn't comment without studying the details first, which I can't in this case.
DitchDigger said:
  1. Is an article a "finished medical device accessory" if it has absolutely no clinical functionality if it's not installed on a medical device, even if it's designed and manufactured specifically for use on a medical device?
Click to expand...
Yes (the emphasis is mine).
 
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