Hello, I have a question that I’m hoping someone here can help me with. Our company wants to put a label onto a product made for us by the OEM. The product falls under Class II for the FDA and IIa within Europe. The OEM is the 510k holder and sells this product globally. Can our company apply labels that list us as the manufacturer and not mention anything about the OEM on it? The design, use and indications will remain the same. Any advice is appreciated. Thanks.
Relabeling Product Manufactured by the OEM
- Thread starter celticfrosting
- Start date
- Tags labeling requirements labels and labeling (general) oem (original equipment manufacturer)
Also, I would like to note:
Our company will be repackaging these instruments. There will be no labeling on the packaging when we receive it from the OEM.
We will add our own instructions for use which mimics the OEMs IFU except only our name will be on it.
We intend to state our company as the manufacturer.
As far as regulatory responsibility: I believe we will be taking full control of as manufacturer though I have read about relabeler and repackager responsibilities that I'm not sure may or may not apply just as easy.
What I'm trying to solve is if we can use the OEMs 510(k) or if we have to submit a new one.
Our company will be repackaging these instruments. There will be no labeling on the packaging when we receive it from the OEM.
We will add our own instructions for use which mimics the OEMs IFU except only our name will be on it.
We intend to state our company as the manufacturer.
As far as regulatory responsibility: I believe we will be taking full control of as manufacturer though I have read about relabeler and repackager responsibilities that I'm not sure may or may not apply just as easy.
What I'm trying to solve is if we can use the OEMs 510(k) or if we have to submit a new one.
Last edited:
If your OEM handles everything (manufacturing, packaging, labeling) EXCEPT distribution to end users (i.e., you are using their 510(k) and function merely as a private-label brand of their product), then you can leave their name off and only say "Distributed By" [your company name].
Since you are repackaging/relabeling the above situation does not apply. You are a repackager/relabeler. You are not a full-blown manufacturer (i.e., you don't need Design Controls and such).
Regarding the 510(k), here's what the FDA has to say:
When a 510(k) is Not Required
[...]
4. In most cases, if you are a repackager or a relabeler and the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications.
Earlier on in the document it states:
The following four categories of parties must submit a 510(k) to the FDA:
[...]
3. Repackers or relabelers who make labeling changes or whose operations significantly affect the device.
Repackagers or relabelers may be required to submit a 510(k) if they significantly change the labeling or otherwise affect any condition of the device. Significant labeling changes may include modification of manuals, such as adding a new intended use, deleting or adding warnings, contraindications, etc. Operations, such as sterilization, could alter the condition of the device. However, most repackagers or relabelers are not required to submit a 510(k).
Reference:
fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm
That said, you are likely OK using their 510(k), registering as a repackager, and building out your QMS accordingly.
Thanks,
~Josh
Since you are repackaging/relabeling the above situation does not apply. You are a repackager/relabeler. You are not a full-blown manufacturer (i.e., you don't need Design Controls and such).
Regarding the 510(k), here's what the FDA has to say:
When a 510(k) is Not Required
[...]
4. In most cases, if you are a repackager or a relabeler and the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications.
Earlier on in the document it states:
The following four categories of parties must submit a 510(k) to the FDA:
[...]
3. Repackers or relabelers who make labeling changes or whose operations significantly affect the device.
Repackagers or relabelers may be required to submit a 510(k) if they significantly change the labeling or otherwise affect any condition of the device. Significant labeling changes may include modification of manuals, such as adding a new intended use, deleting or adding warnings, contraindications, etc. Operations, such as sterilization, could alter the condition of the device. However, most repackagers or relabelers are not required to submit a 510(k).
Reference:
fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm
That said, you are likely OK using their 510(k), registering as a repackager, and building out your QMS accordingly.
Thanks,
~Josh
Would they still have to register as an initial importer? Or would they be simply considered a domestic wholesale distributor? I am a bit confused how to label our company in the eyes of the FDA, in particular we are conflicted on the matter of paying the $4.6k annual fee to register with the FDA.
-aadel
-aadel
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