PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.