Adding claims on medical device labelling

[Sphinx]

I am new to the FDA arena and was seeking some advice on the procedure to add a claim to a class I FDA medical device.

Is there a guidance document I could refer to? Will adding a claim possibly step up the classification of a device?

These are some of the questions that I am looking to get some information on.

 

[Ronen E]

I am new to the FDA arena and was seeking some advice on the procedure to add a claim to a class I FDA medical device.

There is no such (published) procedure that I’m aware of. You simply need to make sure that you and your device continue to comply with all applicable regulations after the addition.

Will adding a claim possibly step up the classification of a device?

It might. It all depends on the specifics.