I doubt you would need to get the FDA involved at all.
There is basically no risk of harm from such a thing. If all you are doing is using it verify whether a surgery worked or not, then it's not actually a treatment is it? Surgeons make their own tools, jigs and tests all the time.
And if for some reason you had to, there are different grades of hard with a medical regulating body. For instance, it is super easy to develop medical tools. Harder again to do implants, harder again to do medicines.
So I want to reiterate. Not hard at all.
- source. Worked for a medical device company that did implants, wound care and medical tools. Surgeons would often ask for custom tooling or jigs through us that we would get made up for them.
There is basically no risk of harm from such a thing. If all you are doing is using it verify whether a surgery worked or not, then it's not actually a treatment is it? Surgeons make their own tools, jigs and tests all the time.
And if for some reason you had to, there are different grades of hard with a medical regulating body. For instance, it is super easy to develop medical tools. Harder again to do implants, harder again to do medicines.
So I want to reiterate. Not hard at all.
- source. Worked for a medical device company that did implants, wound care and medical tools. Surgeons would often ask for custom tooling or jigs through us that we would get made up for them.