
I have been told by some one (FDA consultant) that it can be registered in
510K as medical device. We are planning to discuss with FDA in next month.
My understanding is that the determinative definitions are
here:
A device must be "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory (...)" and must not "achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals (...)."
And: "If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug."
My understanding is that the FDA defines "contrivance" as a mechanical device. I don't know the physical form of your product, but my impression is that it might be an ointment, salve, poultice or bandage of some sort. If you could convince the FDA that the herbal element of your product is insignificant and it's actually a bandage (etc.) with no pharmacologically active ingredients, it might be a device. Such a course, however, would preclude you from marketing it as having special wound care or healing properties, which I gather is the product's point and your goal.
Perhaps we'd understand better if you could share some of your consultant's analysis as to how he/she would get the FDA to consider it a device.