To the first part of the question, I'll speak specifically to the mandate of the health products and food branch and how it relates to health products.
We absolutely have a mandate. Our mandate is to maximize the safety of the products we regulate while minimizing those risks. That contributes to the health and safety of Canadians, so that is absolutely our raison d'être.
On the signing, the requirement is that the practitioner, the requester, sign the form. It's a declaration that the practitioner has actually discussed the risks and benefits of the device with the patient, but there is no requirement for the patient to sign the actual form.