Y
YT Wu
Hello,
I am here to look for some advice from anyone who has had a similar experience or suggestions.
We received 510k clearance for our device a while ago, however, the approved indications for use were broad terms such as improve local blood flow circulation and relief of muscle pain. We later conducted tests and researches would like to market our device with a new indication for use: wound healing. We can tell from clinical aspects and from physiology that increasing local blood flow wound is beneficial for wound healing, but we are not sure if this is available without filing a traditional 510k to alter the indications for use.
And if without altering, can we passively provide (actively is prohibited for sure lol) this "off-label use" information, such as scientific research or journal publications, to consumers?
Does anyone have experience with this?
Many thanks for reading.
I am here to look for some advice from anyone who has had a similar experience or suggestions.
We received 510k clearance for our device a while ago, however, the approved indications for use were broad terms such as improve local blood flow circulation and relief of muscle pain. We later conducted tests and researches would like to market our device with a new indication for use: wound healing. We can tell from clinical aspects and from physiology that increasing local blood flow wound is beneficial for wound healing, but we are not sure if this is available without filing a traditional 510k to alter the indications for use.
And if without altering, can we passively provide (actively is prohibited for sure lol) this "off-label use" information, such as scientific research or journal publications, to consumers?
Does anyone have experience with this?
Many thanks for reading.