Who is responsible for ensuring that devices designated prescription only are, in fact, used only under prescription conditions?
I'd brought this up in a previous post regarding a number of discussions surrounding implications of a device designated as prescription only in the US, but the thread kindof veered away from this particular question, so thought I'd start a new dedicated thread.
So, who is responsible? How is it checked? To what degree is it enforced?
If you are a manufacturer selling directly to an end-user, are you responsible for confirming that the device is used only "under the supervision of a practitioner licensed by law to direct the use of the device", prior to sale?
If you are selling through a distributor, is this responsibility (with distributor) typically specified in writing?
If you sell to a clinic/medical-facility, is the clinic/facility responsible?
If the device is found NOT being used "under the supervision of a practitioner licensed by law to direct the use of the device", and there is an adverse event, who is liable? (manufacturer vigilance activities aside)
...or, is the "Rx Only" designation on the label simply treated like a warning or contraindication, and it is the responsibility of the end-user to abide by (hence no additional controls/pre-sale criteria by the manufacturer are necessary)...?
I'd brought this up in a previous post regarding a number of discussions surrounding implications of a device designated as prescription only in the US, but the thread kindof veered away from this particular question, so thought I'd start a new dedicated thread.
So, who is responsible? How is it checked? To what degree is it enforced?
If you are a manufacturer selling directly to an end-user, are you responsible for confirming that the device is used only "under the supervision of a practitioner licensed by law to direct the use of the device", prior to sale?
If you are selling through a distributor, is this responsibility (with distributor) typically specified in writing?
If you sell to a clinic/medical-facility, is the clinic/facility responsible?
If the device is found NOT being used "under the supervision of a practitioner licensed by law to direct the use of the device", and there is an adverse event, who is liable? (manufacturer vigilance activities aside)
...or, is the "Rx Only" designation on the label simply treated like a warning or contraindication, and it is the responsibility of the end-user to abide by (hence no additional controls/pre-sale criteria by the manufacturer are necessary)...?