Addition of Label by Initial Importer



Hi All,

I have a question regarding our Initial Importer and adding a label to our packaging. We supply them with samples for customers that the Initial Importer is not charged for. (These are sterile product identical to commercial saleable product.) They want a method of tracking these separate from commercial product that they are charged for.

They propose adding an "E" to product code on the samples in their inventory and to add a label "Sterile Samples, Not for Resale"

There is a specific line in the Initial importer definition that seems to prohibit any type of relabelling.

An initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.

Is this considered relabelling and what are our resposibilities as legal manufacturers here. Do we need 510K or note to file or is this the responsibility of the Initial Importer?

Thanks for your help,



You could call FDA DICE (formerly DSMICA) and ask them.

My view is that the proposed actions are not relabeling. In relabeling, the regulatory label is replaced, such as by covering it over with another label. This might be done for instance in order that the Initial Importer could change the top-line name on the product to their own.

In your scenario, regulatorily non-significant supplemental labels are to be added, for the reasonable purpose of better controlling product distribution. I gather that no regulatorily significant information will be covered over or removed and replaced.

Ronen E

Problem Solver
I generally agree with MIREGMGR.

They propose adding an "E" to product code on the samples in their inventory and to add a label "Sterile Samples, Not for Resale"

Someone needs to make sure that those additions are made in a way that doesn't compromise or jeopardize the sterile barrier for the stated shelf life.



Thanks for your input Everyone,

Does that mean that we should not add an E to the regulatory label as the actual product code in the 510K does not have this letter added. Would it be better to place the amended product code a separate label for identification?

Would we as legal manufacturer need a note to file to our 510K or should the initial importer document this in some way?

To what extent do we need to control what our initial importer does?

Best regards,

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