Minimum US FDA Labeling Requirements for a Class II Medical Device

Silvertabb said:

Assume there is a class II device containing the following components:
(1) battery door
(2) antenna
(3) standard screws use to fasten the antenna to the device

If customers call in and say that the device they received is either missing the battery dooror the antenna was broken, the company wants to have separate SKUs for warranty replacement.

For the US Market, what is the minimum labeling requirements the company must compy with? When responding, it would be great if you provide a regulation number, guidance name, or other source.

thanks

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The Specialist said:

There is nothing to stop you from having unique identifiers for each of the components you list.

Of course, the component does not have to be 'marked' with the SKU. This can just be a paper excersise (e.g. spare parts list in manual/tech document).

I can't quite see where FDA labelling requirements come in? Am I missing something?

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