Hi,
I'm currently running the development for a device meant to be used in cancer surgery to image and find microscopic areas of cancer. The goal is to get some early data from device with an ITA to see if it has potential.
In it's guidance document, Health Canada mentions that all unlicensed medical devices above Class II require an ITA, along with any previously approved device that is being studied for a new indication of use.
In terms of regulations, it is possible to either get the device licensed as a Class I imaging tool and then studied, or not licensed and approved for direct data collection as an investigational device. Since REB authorization is required before doing studies, I was wondering whether or not a device has already been licensed by Health Canada affects the review process. Hopefully my question makes sense (let me know if it doesn't)!
I'm currently running the development for a device meant to be used in cancer surgery to image and find microscopic areas of cancer. The goal is to get some early data from device with an ITA to see if it has potential.
In it's guidance document, Health Canada mentions that all unlicensed medical devices above Class II require an ITA, along with any previously approved device that is being studied for a new indication of use.
In terms of regulations, it is possible to either get the device licensed as a Class I imaging tool and then studied, or not licensed and approved for direct data collection as an investigational device. Since REB authorization is required before doing studies, I was wondering whether or not a device has already been licensed by Health Canada affects the review process. Hopefully my question makes sense (let me know if it doesn't)!