TGA Approach to Predetermined Change Control Plans

Overview

We are seeking feedback on a draft guidance document outlining our approach to predetermined change control plans (PCCPs).  

This guidance has been developed to outline how PCCPs can be used to gain premarket regulatory approval to implement a change at a future stage.

This guidance applies to medical device software, including software as a medical device (SaMD), software embedded in, or driving, other devices and in vitro diagnostic (IVD) software. It is particularly relevant to artificial intelligence or machine learning (AI/ML) enabled medical device software that is updated iteratively or where the model is re-trained.

Please review the linked document below (under 'Related') and answer the following 6 questions.

What happens next

We will process the feedback received and revise the draft guidance accordingly.