Is it acceptable it is to list new products under an existing 510(k)?

Hi,

I can understand both points of view to be honest, so I'm still not sure which thought process is best to go with.

For example we could manufacture a device and sell it to another company in America. Therefore, the labelling would be branded with their logos etc...

If we were to sell this same device to a second company, it would involve a non-significant change to the labelling to update the branding on the labelling.

However, following the train of thought that if the 510(k) was cleared for one device (and one device only), would that mean that we would have to submit a new 510(k) even though the only difference between the two devices would be the artwork on the packaging?

If you are rebranding the same product for a different client then a note-to-file is acceptable as FDA does not approve labeling for 510(k)-cleared products.

I agree. In the case of two private label customers selling what otherwise is an identical or not-significantly-different device product, for 510(k) purposes there is only one product.

FDA cares about regulatorily significant changes to labeling content. The name of the private label customer is not regulatorily significant.

One more thing worth to notice...
As far as I know, if your product is a IVD device, you may have to submit another CLIA (add-to-file) when you change device name or distributor.

MIREGMGR said:

Consult the various 510(k) related guidances. FDA's language is significant; when they write "device" (singular), that's what they mean.

Click to expand...

I would say that's a very long way from explicitly saying anything.

If you go through the flowchart and determine that no new submission is required, what you have determined is that A, B, C, D, and E, are, from FDA's perspective, all the same device, cleared under the same 510(k). The differences among them may be meaningful from a manufacturing or marketing perspective, but what the flowchart tells you is whether those differences are meaningful from a regulatory perspective.

Hi Team,
I have one query regarding requirement of 510k submission in following scenario:
Suppose, we have 510k for cleared class II instrument, say example Screw driver .Later on we modify this device with one new features ( for better engagement of screw) as per the customer requirement and considered as it as new device and assigned new part number for identification. We wish to keep original 510k cleared device. This change may not impact on intended use . So, my question is that can we add this new instruments with new part number in our existing 510k or whether we require special 510k submission or can we do "note to file or letter to file. Please guide us in this scenario.

Thanks
Haresh N

Haresh said:

Hi Team,
I have one query regarding requirement of 510k submission in following scenario:
Suppose, we have 510k for cleared class II instrument, say example Screw driver .Later on we modify this device with one new features ( for better engagement of screw) as per the customer requirement and considered as it as new device and assigned new part number for identification. We wish to keep original 510k cleared device. This change may not impact on intended use . So, my question is that can we add this new instruments with new part number in our existing 510k or whether we require special 510k submission or can we do "note to file or letter to file. Please guide us in this scenario.

Thanks
Haresh N

Click to expand...

Reference the guidance. There's a flow chart in there.