A device used in a situation of special access is likely to be pioneering (as by the rules of the SAP, no currently available device offers the same life-saving abilities), and therefore is also likely to be somewhat experimental and under development - changes must be common.

My question is related to change control of such a device. I suspect the manufacturer should handle it in the same way as a normal licensed device but the regulations/guidance doesn't address this.

Anyone have any experience with a medical device marketed under Health Canada's Special Access Programme?

Any answers ?