Hi All. Hoping someone can help clarify this for me. I understand the concepts of off-label use of devices, and as a distributor of medical devices, we always advise customers of what the device is indicated for and that we do not advise using the device outside of what that indication is. We have our customer's sign at the time of sale an agreement that states they are aware of the indications for use and if they use it off-label and an event occurs, we are not liable. But what is grey for me is if a device is cleared outside of the USA for let's say use at a depth of 3mm but it is capable of going to depths of 6mm, is it required that we lock the device settings at a max of 3mm before it is imported? Or can this device be imported unlocked (able to go up to 6mm) and we have our customers sign disclosures that the device is indicated only for 3mm and we are not liable for use above that depth?
Off Label Use
- Thread starter margadia
- Start date
thank you! this is so helpful!
@shimonv beat me to it ... what's the risk?
I think that if you are aware of the off label use, you should at least cover it in risk management. It starts to creep into User Needs if it's a common use scenario. I guess I questions are why the design allowed the extra depth, and why clearance to that depth wasn't considered / desired.
I think that if you are aware of the off label use, you should at least cover it in risk management. It starts to creep into User Needs if it's a common use scenario. I guess I questions are why the design allowed the extra depth, and why clearance to that depth wasn't considered / desired.
