Good morning,

I'm working in a french company which develop medical device Class II (neuromuscular stimulator).
We have just obtained the premarket notification 510(k) for our product.
We are developping the labelling of the device.
The manager ask me if we can put a FDA logo (see attached document) on the label of immediate packaging of the device. (To tell the truth, he asks me a lot of question and I cannot answer it)

I read the regulation (chapter about labelling, misbranding) and I can't decide if we can or not put this logo on the packaging or in the instruction manual accompanying the device.

What can we do in order to communicate about the fact that the FDA permits our medical device to be marketed in US? And more precisely on the label or labelling (instruction manual for exemple).

Another question : could we put the FDA 510k premarket notification number on the label or labelling (instruction manual for exemple)?
Or a phrase concerning the premarket notification 510k of our medical device

Is it prohibited by US regulations ?


Thanks you for your help

The manager ask me if we can put a FDA logo (see attached document) on the label of immediate packaging of the device.

I read the regulation (chapter about labelling, misbranding) and I can't decide if we can or not put this logo on the packaging or in the instruction manual accompanying the device.

What can we do in order to communicate about the fact that the FDA permits our medical device to be marketed in US? And more precisely on the label or labelling (instruction manual for exemple).

Another question : could we put the FDA 510k premarket notification number on the label or labelling (instruction manual for exemple)?
Or a phrase concerning the premarket notification 510k of our medical device

Is it prohibited by US regulations ?

Hi noemie,

I am not sure of the specific legality, but it sounds like a really BAD idea. The FDA will certainly object to you "branding" your product with their name and logo, and I am sure they will think of some way to ensure that you get hit with a mislabelling citation, probably before the ink is dry!

I have always been told that the FDA never "approve " a 510K, they only "do-not-object" to it, thus anything suggesting that they endorse your product will get an immediate reaction - and not in a good way.

Hopefully someone on the Cove can advise you of the chapter and verse of why this is a bad idea, but think of it this way - if this was allowed, wouldn't everyone be doing it?

Good luck,

Jimmy

From:
Labeling
Regulatory Requirements for Medical Devices

A device can be misbranded by making reference to a medical device registration, or a510(k) premarket notification number assigned by FDA in response to a firm's filing requirements under the FD&C Act. Section tf 07.39 of 21 CFR, Misbranding by reference to establishment registration or registration number, and 807.97 of 2 1 cfr, misbranding by reference to premarket notification, state that the assigned numbers do not constitute official FDA approval of the device. Additionally, any representation that connotes FDA approval as a result of complying with the devlce regulations is misleading and constitutes misbranding