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We have a class 2 medical device that is sold to medical spas and doctors. It is a laser used for aesthetic purposes. Each state also has their own regulations on who is allowed to use the device. So for example in some states the Dr needs to be within 5 miles of the facility while other states the Dr needs to be the one operating the device
1. Does a physical label need to be on the device. I feel there are conflicting stories
2. Does some labeling need to be in the owners manual
3. Do we need to collect documentation from each "buyer" or can we have them sign something on a sales agreement that says this device is for Rx use only and you should also look to your state laws? In many states the buyer will not be the doctor but the spa that the Dr is associated with.
4. Is there a FDA guideline on who can use a prescription device that trumps state laws? If so where is that guideline
thanks,
1. Does a physical label need to be on the device. I feel there are conflicting stories
2. Does some labeling need to be in the owners manual
3. Do we need to collect documentation from each "buyer" or can we have them sign something on a sales agreement that says this device is for Rx use only and you should also look to your state laws? In many states the buyer will not be the doctor but the spa that the Dr is associated with.
4. Is there a FDA guideline on who can use a prescription device that trumps state laws? If so where is that guideline
thanks,