Approval for supervised and self-testing are two separate approval processes. Instructions will need to be simplified, a consumer help line should be available, and the step by step process for the users should be simple to follow. I assume this is what the TGA will be assessing in its review process for devices that have already proven efficacy (already approved for supervised use). A whole new device not currently listed will obviously need to provide all supporting data from tests and trials etc.
Media Update, page-1055
-
- There are more pages in this discussion • 791 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
