Posted by Michael Wonder on 19 Jun 2017
Accelerated assessment of medical devices - priority review pathway
19 June 2017 - The TGA sought comments from interested parties on the consultation paper for accelerated assessment of medical devices - priority review pathway.
The Expert Panel Review of Medicines and Medical Devices Regulations 2016 includes regulatory reforms for medical devices to expedite assessment of certain medical devices that are identified as 'novel' using a priority review pathway.
In response to the reforms to establishment a priority review pathway, this paper provides, for public consultation, the proposed criteria for what constitutes a 'novel' medical device and an approach to implementation. The priority review pathway will require medical devices to meet the essential principles, including clinical evidence requirements, while expediting assessment through administrative changes. Development of this pathway also will require the establishment of business process for applications for priority review status. The consultation paper outlined proposed business processes and timeframes.
