melissa66
20th March 2008, 11:28 AM
I have not been able to find any restrictions on the use of a prescription device as a predicate for a device which we have for OTC. Since I am not sure, I have been looking for a predicate which is an OTC medical device. However, all I can find is Rx medical devices. I found a product that says a consultation is recommended before ordering the product; I don't think their is any restrictions from ordering it. Unless, after you put in an order and they ask for the prescription or physician; but I don't really want to buy it, so I didn't try. This product is sold by a Canadian company. My question is that if something is approved by the FDA for prescription use, can it be sold over the counter in Canada? Does anyone know how to find devices approved/licenced by Health Canada? Maybe it was approved OTC in Canada.
