UDI, Labeling Accessories, General Insanity, Etc.

DitchDigger

Starting to get Involved
#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.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
  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?
Yes, subject to effective dates.
  1. Do most of you think that an accessory like this needs to be uploaded to GUDID and labeled with a UDI?
I wouldn't comment without studying the details first, which I can't in this case.
  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?
Yes (the emphasis is mine).
 
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