The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
If your device is intended for the monitoring, treatment, prevention or diagnosis of a life threatening or seriously debilitating condition; and there is currently an unmet need for your device; and your device represents breakthrough technology or provides a clinical advantage (or public health need for IVD medical devices), you may qualify for Priority Review designation, which will allow your application 'front-of-queue' priority status.