New Year’s Resolution : No Fowl play with labelling in 2013
One of the things we come across often in our practice is overly creative positioning of a medical product. In a wish to minimise (or even avoid) a regulatory burden, the client wants to label a product as something it clearly is not. Examples include IVDs marked as “Research Use Only” in an attempt to completely avoid requirements for product registration, while at the same time including detailed clinical use instructions on the product brochure. A contemporary example of such wishful thinking is the plethora of tablet and phone apps which provide ability to view and make measurements of diagnostic images, but labelled with a screen banner saying “Not for Diagnostic Use”.
The problem is that the definition of a medical device in most jurisdictions includes both things that are marketed for therapeutic or diagnostic purposes and also items that appear or could be taken to be for medical use. For example s41BD of the Australian Therapeutic Goods Act states that the purpose of a medical device is to be ascertained according to the labelling – including very broadly:
“…(a) the labelling on the main equipment;
(b) the instructions for using the main equipment;
(c) any advertising material relating to the main equipment;
(d) technical documentation describing the mechanism of action “
In other words: the totality of presentation is what matters, so a disclaimer really doesn’t carry much weight. We call it the “Quacks like a duck” argument. If it looks, walks and quacks like a duck – then it’s a duck, no matter what else you claim it to be. Such marketing practices don’t go unnoticed for long – usually only as long as it takes for your competitor to tip off the regulator, and then the evidence is there in black and white on the label – of deliberately marketing a therapeutic product disguised (“misbranded”) as something else and that’s a crime in most jurisdictions.
So… as your thoughts turn to the Christmas feast, remember… don’t be a goose, if it quacks like a duck, you can’t pretend it’s a turkey.