Fiona McCormack | Director, Devices Emerging Technology Section
Therapeutic Goods Administration

Fiona McCormack is a dynamic leader in the medical device industry, currently serving as the Director of the Devices Emerging Technology Section at the Therapeutic Goods Administration (TGA). With extensive regulatory and technical knowledge across multiple sectors, Fiona leads a dedicated team of technical and strategic policy specialists working to ensure that emerging technologies available in Australia meet the highest standards of safety and performance. At the Digital Health Festival 2026, Fiona will share her insights on how the TGA is engaging with stakeholders across a complex and rapidly evolving digital health landscape while working to deliver on the outcomes of TGA’s legislative review into the regulation of software and AI-based medical devices, as published in July 2025. Current priorities include the review of Australia’s regulatory requirements for Digital Mental Health Tools, and forthcoming measures to improve transparency and access to information for digital therapeutic goods that are accessed through virtual and online environments.