Labeling for Repair Parts of a Medical Device

J

jlhaney63

#1
We are the manufacturing site for a medical device in the USA. I am being asked to ship components and sub-assemblies to another state in the USA and also to Germany to support service/repair centers that will repair the devices and return them to the user. I'm trying to understand the labeling requirements for these components and sub-assemblies.

I found 21 CFR Part 801.122 that states:

Subpart D--Exemptions From Adequate Directions for Use Sec. 801.122 Medical devices for processing, repacking, or manufacturing.
A device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the act if its label bears the statement "Caution: For manufacturing, processing, or repacking".

However, I'm not sure that this applies as I am shipping components and sub-assemblies, not fully functional medical devices.

Is anyone aware of any labeling requirements for repair/service parts?
 
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M

MIREGMGR

#2
Regulatory systems including US FDA aren't good with boundary situations. FDA is only allowed to create regulations for medical devices. This causes them to not do a good job of documenting how to handle non-devices.

If the thing you're shipping might be thought to be a device by someone that interacts with it, even if you know it to be not intended to be seen as a device, then I'd proceed to treat it as a device, document why you're doing so, and label it per the rule you've identified. I'd add to the regulation's required statement this additional statement: "Component/sub-assembly for service and repair. Not intended to be used as a finished medical device."

If on the other hand the thing you're shipping clearly isn't a finished device and could not be used as such, then make sure that the labeling you apply to it is distinctly different from the labeling you use on the finished devices you make, in addition to clearly identifying the thing as a non-device using language like the above-suggested statement.
 
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