Australia Proposes New Priority Review Pathway for Medical Devices

Australia’s regulator outlined a new priority review pathway for medical devices and is asking industry for feedback on its proposal.

The recommendation is part of a regulatory overhaul intended to speed the review of “novel” medical devices and reduce regulatory burdens.

The Medicines and Medical Devices Review Panel also determined that an expedited review pathway should be consistent with the U.S. FDA’s priority review pathway. — Tamra Sami