Hi Ann.
I think the key issue here is that any sort of "off-label" use brings the obvious attending danger of changing the device classification from Class 1 to Class 2 or even Class 3. My understanding of the regulations (and I am not by any means an expert in medical device regulations!) is that the product code can often depend on the exact wording of the use which at the same time can, in the above situation, change the product code for your exempt class 1 into a different product code which could easily change the classification.
As an example, in a prior company we had a product that, depending entirely upon what we said the product did, could be classed as either class 1 or class 2. Well, we were not a device company (this was essentially a one-off for one of our brands) so we ensured that the claims were all linked back to the class 1 product code uses and avoided an additional unbudgeted expense by not having to put together and file a 510(k) for the device. I can't speak with certainty about the prevalence of such issues within the regulations because I don't work in the device area enough to have any data on it, but based on the way the two product codes we were looking at were written I have to think that this is not an unusual situation and would guess that this is a problem that is routinely encountered.
So if you are planning to go off-label, I suggest being extremely careful to ensure that your new off-label use is not something that is going to make your product classification change.
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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
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Original Message:
Sent: 26-Mar-2020 15:50
From: Ann Kemp
Subject: Off Label Use
Hi,
Does 21 CFR 99 apply to a Class I device? I assume so, but a Class I exempt device isn't approved, cleared or licensed.
Per the regulation:
(a) A manufacturer may disseminate written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling for an approved drug or device or in the statement of intended use for a cleared device, provided that the manufacturer complies with all other relevant requirements under this part. Such information shall:
(1) Be about a drug or device that has been approved, licensed, or cleared for marketing by FDA;