If a Band-Aid designed specifically for your finger is used on your arm, is it still a Band-Aid?
That may seem like a simple question, but if you are trying to decide whether your device needs a de novo submission, that simple question can lead to others.
Do you have safety and efficacy data for use of the Band-Aid on the arm? Or just for use on the finger? Does using the Band-Aid on your arm have benefits that outweigh the potential risks?
OK – so using a Band-Aid on your arm instead of your finger may not have any inherent risks. But the risk-benefit argument is still something to consider when choosing the FDA path for your device.
There are many different and creative pathways to FDA clearance and approval, so find some time on my calendar and let’s rip off that Band-Aid and find the path that works best for you.