Regulatory Open Forum

 View Only
Reg Intel Conference 2024
Back to discussions
Expand all | Collapse all

Intended and Indications for Use - Potential Off-Label Use

  • 1.  Intended and Indications for Use - Potential Off-Label Use

    This message was posted by a user wishing to remain anonymous
    Posted 12-Sep-2019 09:28
    This message was posted by a user wishing to remain anonymous

    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 part of the device for both intended/indications for use, but another piece would apply to the intended use only. 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?


Related Content