There is a long history with FDA regarding off-label use. FDA's perspective and interest has waxed and waned over the years. Not sure where it stands right now, except generally on shaky ground, sigh.
To me this is about the data that you have to support your claims and the level of risk your device poses to patients when used "as intended," meaning for the use that you claim it is good for. It can be easier to get a device through FDA for general surgical use than for a specific use. That is because, for the former, you just need data that support its use for "whatever." For example, you conduct a clinical trial in which the device is used for whatever surgery the surgeon wants to use it for. (Think suture.) The trial results will most likely reflect safety and effectiveness across a range of procedures combined.
Now consider what happens if you advertise for a specific use. Then more surgeons will start to use it for that type of procedure. It may turn out that the device is more or less safe or effective for that particular procedure than for the range of procedures included in your trial. (This is why I say "average" can be used to cover a variety of sins.) FDA's concern is, of course, that it might be less safe or effective. In that case, you are encouraging more surgeons to expose more patients to a device that is higher risk for those patients, than for the general surgical patient population, and without adequate data to determine how safe and effective it might be.
I think this is a gray area. The surgeons are not actually using it "off-label," because the label is for whatever, and that essentially means any and all types of procedures. However, if you are in any way encouraging a specific use, then FDA may decide are marketing it for an uncleared use, because your clearance is for general use only.
The other situation is that you already market it for one or more specific uses and surgeons are using it for specific use that is not one of those specific uses. Then they are clearly using it off-label. If you are in any way encouraging a specific use that is not one of the specific uses that is covered by your FDA clearance, then you are being very, very bad. :)
Another gray area is determining what behaviors you might engage in that FDA could decide are "encouraging" off-label use. Here is where there has been some waxing and waning over the years. Sometimes off-label use is a hot button for FDA, other times, not so much. At some point, it stretched to something like "if it could be reasonably inferred that your device could/would be used for (maybe even "more often"), then you were on the hook for that intended use, I guess on the theory that, merely by marketing it for surgical use, you were really marketing it for that specific use. (I have seen at least one device for which this was clearly the case, although FDA never made a fuss about it, probably because it was so safe as to be boring, and had established that track record at a time when off-label use was not a hot topic with FDA.)
Finally, things got a bit murkier still (IMO) when FDA decided (or was made to understand) that, even though you couldn't "encourage" off-label use, if surgeons were using your device off-label, their patients would be better served if you shared whatever data and information on that specific use you might have. This moved the line, which was previously drawn between "encouraging" versus "not encouraging," to between "encouraging" and "informing," which I think is a lot fuzzier. Loosely put, it seems to have settled out that, if you only provide information if a physician asks, you are "informing." If you provide information that the surgeon has not requested, you are "encouraging."
Perhaps more than you wanted to know, but it took me forever to work all this out in my head, so I share it now and then for anyone who might be trying to work this out for themselves. Of course, I could be totally wrong, but it's at least a conceptual model that has made things less murky for me (or at least made the murkiness clearer to me, LOL) and has so far not led me wrong.
And now maybe some folks here who have grappled with the murk more recently than I have can clarify where I'm wrong and also update you as to where FDA is these days, on its waxing and waning.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 23-Sep-2020 03:50
From: Stefan Maartense
Subject: not having regulatory clearance
Hi thanks for you swift reply. In this case it is about the use of medical devices in the US. We have a discussion on whether a certain usage/surgical procedure is off-label, since it is not in the indications. But some colleagues are of the opinion that the indications could imply the use of the device in that way, so it would not be off-label, only not having regulatory clearance? Especially since the procedure is not mentioned as a contra-indication.
This seem to be a very grey area, if we interpret it this way, in my opinion. Or is this grey area allowed for US FDA? It makes for example handling of complaints a lot vaguer adding a third category "not having clearance"? It is not allowed for EU-MDR, there indications have to be very specific and data has to be provided to show safety and performance.
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Stefan Maartense
MD, PhD
Amsterdam
Netherlands
Original Message:
Sent: 22-Sep-2020 14:23
From: Victor Mencarelli
Subject: not having regulatory clearance
At least in the US there might be a difference - not having clearance would effectively imply to me that you cannot sell the subject product for any purpose whatsoever. Off-label use is where you have a product cleared for sale for one indication but that someone has decided to use for a different purpose. That can be legal if that is done in the practice of medicine because the US FDA does not regulate the practice of medicine so once a product is cleared for marketing for any indication then a healthcare provider can legal use it for any indication that they consider effective.
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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
Original Message:
Sent: 22-Sep-2020 11:19
From: Stefan Maartense
Subject: not having regulatory clearance
Hi
Can somebody help me out. Is there a difference in: "not having regulatory clearance" and "Off-label use".
From me personal logic I would say there is no difference, but I might be missing something here.
Thank you for your help in advance.
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Stefan Maartense
MD, PhD
Amsterdam
Netherlands
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