I'll be quite clear from the start. In my presentation, and from what we've heard today, the intention, as we understand the proposed bill, is that these will be class II medical devices.
The current wording of the proposed amendment deems a non-corrective contact lens to be a class II medical device. Unfortunately, that wording will likely not suffice in protecting consumers, because the definition of a device resides in the Food and Drugs Act. The proposed wording right now speaks to amending the medical devices regulations by deeming a lens a class II medical device.
Before we go there, because a non-corrective contact lens has no therapeutic purpose it does not meet the definition of a device in the Food and Drugs Act. So the bill would have to be changed to deem, within the Food and Drugs Act, that a non-corrective contact lens outside of the definition of device is deemed to be a device. Once that occurs, the regulations will apply.