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Potential Off-Label Use question

tebusse

Involved In Discussions
#1
Greetings,

I have a few questions pertaining to intended use, indications for use and how to determine if a device is being used per the label or off-label.

I understand the definitions of intended use and indications for use in addition to the fact that the indications are subsidiary to and fall under the umbrella of the general intended use statement. However, I'm having difficulty applying it to a particular situation.

Our device may be used for a clinical study in which the site would use the device for the intended use, but not for the indications. For example: the device's intended use states that is intended to dynamically measure the presence of radiopharmaceutical in an organ or body region during the uptake period as part of nuclear medicine procedures. Whereas the indications for use states that it is indicated for use as a tool to help assess whether a radiopharmaceutical injection remains near the injection site rather than circulating in the vascular system, which is required for a nuclear medicine procedure.

The device has two sensors and while one sensor would follow the intended use and indication, the other sensor would be placed over a organ only during the uptake period and not near the injection site (only follows the intended use).

Would this be an example of off-label use?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
Whereas the indications for use states that it is indicated for use as a tool to help assess whether a radiopharmaceutical injection remains near the injection site rather than circulating in the vascular system
I'm confused. I thought that normally Indications For Use are the medical conditions that the device is intended for.
 

tebusse

Involved In Discussions
#3
Ronen,

Simply put:

Intended Use=what the device is to be used for.
Indications for Use=the conditions, situations, or reasons for using the device.
 
#4
I would say from your description of the situation, it does not represent off-label use. Off-label here would be if you had another indication that was very specific.

Even then, since it's for a clinical trial, this likely would be easy to manage if it was determined to not be a significant risk. You'd present your new labeling and case to the IRB (Institutional Review Board) and if they agree, you'd move forward.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
Indications for Use=the conditions, situations, or reasons for using the device.
Yes, but the description above makes me think your org is misinterpreting this definition.
To me, both what you stated as "intended use" and "indications for use" would fall under Intended Use. What you wrote under "indications for use" is the hi-level intended use - what the device is used for. Then what you consider as the "intended use" is essentially the same, maybe a little more technically specific ("dynamically measure the presence... in an organ or body region... during the uptake..." vs. "assess whether... remains near the injection site").

To me, "reasons for using the device" would be more about the patient's situation and how it triggers the use of the device.

On the other hand, if the FDA is happy with your interpretation then that's all that matters and please feel free to ignore my comments.
 

tebusse

Involved In Discussions
#6
Yes, but the description above makes me think your org is misinterpreting this definition.
To me, both what you stated as "intended use" and "indications for use" would fall under Intended Use. What you wrote under "indications for use" is the hi-level intended use - what the device is used for. Then what you consider as the "intended use" is essentially the same, maybe a little more technically specific ("dynamically measure the presence... in an organ or body region... during the uptake..." vs. "assess whether... remains near the injection site").

To me, "reasons for using the device" would be more about the patient's situation and how it triggers the use of the device.

On the other hand, if the FDA is happy with your interpretation then that's all that matters and please feel free to ignore my comments.
Ronen,

The FDA used the company's intended use and indications for use to assist with the device's classification and determination. Additionally, we've been through a few informational meetings with them regarding this device. They seem to be okay with the way intended use and indications for use are being applied.

Regardless, I'm still trying to determine if this is on or off-label use.
 
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