FDA Marketing Claims - What is and isn't allowed


Involved In Discussions
Hi all! I'm getting a bit confused regarding what is and isn't allowed regarding a medical device's product claims.

Some of our American partners are extremely cautious about what we can mention in marketing material and insist that we cannot make any statement about the device which is not mentioned in the 510(k).

For example, as part of the 510(k) we have a study which shows that our device is SE to a predicate device. However, we also have data (not in the 510(k)) showing that the device is "easy to use". Our partners are stating that we cannot say that the device is easy to use and can only say it's SE compared to the predicate in our marketing material.

Most of the issues relate to when we are trying to make statements such as the device has a certain attribute, or achieves a certain performance. We never make any claim that the device can be used outside the intended use in the 510(k).

As far as I'm aware as long as we aren't changing the intended use of the device or making false or misleading claims about the device we should be okay. Also, as the 510(k) is a clearance and not an approval, the FDA aren't approving the content/data in the 510(k) for use in marketing materials. Which makes me think that we can use any data on the device we have as long as it's not false?

Any help would be appreciated. Cheers!


Super Moderator
Well, I'll toss in my $.02 in the hopes it at least spurs on the discussion.

I am probably equally paranoid when advising clients on website content (and the potential for making claims that might draw attention).

Statements such as "easy to use" can be construed as claims and unless you have some data substantiating it (e.g., user studies where ease of use was scored high) then technically it could be considered misbranding.

Several years ago, Cheerios (oat cereal) was advertising that it was "heart healthy" or some such. FDA started posturing saying that if they were making such claims, it had to be regulated as a medical device with clinical data supporting it. I don't recall what the outcome was but just the swirl that it caused had an impact on my thinking.

It probably boils down to a couple of things: the 'audacity' of the claim (something like "this is the best device ever developed" would probably get more attention over "easy to use") and the risk of the device (an "easy to use" tongue depressor won't get the attention an "easy to use" MRI device).

I would tend to err on the side of caution, eliminating (or minimizing) unsubstantiated claims. But that's just me.

Mark Meer

Trusted Information Resource
...insist that we cannot make any statement about the device which is not mentioned in the 510(k).

This, in my opinion, would be an overly conservative approach.

For example, you might collect customer reviews, or perform other post-market surveillance. By your partners' approach, you wouldn't be able to use this information to market the device, simply because it wasn't in the original 510(k)??

I agree with your position and yodon's:
- Don't make claims that contradict or modify the stated intended use
- Have evidence to back up any statements you make


Involved In Discussions
Thanks Yodon and Mark, you've confirmed what I was thinking, that the 510(k) is not the only source of information we can use for making claims. That's good to have some reassurance.

I guess we will still have to bow to our customers needs if they are overly cautious though!
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