Medical Device Relabeler Obligations

Ronen E

Problem Solver
Moderator
"In most cases, if you are a repackager or a relabeler you are not required to submit a 510(k) if the existing labeling or condition of the device is not significantly changed."
This is a little bit of an oxymoron - If the labeling is not significantly changed, it's not Relabeling.

"The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications."
This is useful only if you actually have access to the labeling submitted in the 510(k).

- suggests that relabelers do not need to submit a 510k in a scenario where it is only the branding of the labelling that is being changed. This would apply to most of the products in the scenario I envisage, i.e. the relabeler is just going to put the OEM product in their own cartons, preserving all the necessary labelling information but with a different brand ID on the cartons.

1. Where *only* the branding of the labeling is being changed it is not typically considered Relabeling, but rather "own brand labeling" or "private labeling". FDA has specific (different) rules for these.

2. "Just putting the OEM product in their own cartons" might be Repackaging - depending on whether there are more layers of packaging inside those cartons.

Cheers,
Ronen.
 
R

Reinheitsgebot

I see you find FDA guidance oxymoronic! - no doubt your earlier posts imploring me to search this guidance with the proverbial fine-toothed comb were all in a spirit of fun:tg:
 

Ronen E

Problem Solver
Moderator
I see you find FDA guidance oxymoronic! - no doubt your earlier posts imploring me to search this guidance with the proverbial fine-toothed comb were all in a spirit of fun:tg:

I never suggested that the FDA is perfect. Nevertheless, the FDA website is a great resource, and your best bet if you want to do it on your own.
 

Marc

Fully vaccinated are you?
Leader
I see you find FDA guidance oxymoronic! - no doubt your earlier posts imploring me to search this guidance with the proverbial fine-toothed comb were all in a spirit of fun :tg:
The folks here like Ronen who try to help here are volunteering to help answer questions people have.

You will find in regulated industries such as medical devices, pharmaceuticals and such, companies are each different as are their products. Since many people do not put in all the necessary specifics in their question(s) they are often hard to directly and specifically answer. It is very typical for people trying to help to point to sites such as the FDA website for more specifics, even though often websites like the FDA's are not always clear on many issues, and are sometimes contradictory, but these are things you should read and know about.
 
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