Australia Follows FDA and IMDRF Lead in Regulating Software
Australia’s Therapeutic Goods Administration will likely follow the FDA’s lead and the International Medical Device Regulators Forum’s model for regulating software for medical devices.
The TGA is a founding member of the IMDRF and the agency is participating in the working group tasked with developing and harmonizing approaches to the regulation of standalone medical device software including mobile medical apps. The FDA’s draft guidance on SaMD was also prepared by IMDRF.
Just as the TGA first determines what a device’s intended purpose is, the same would apply for software that will be regulated as a device, said David Hau, medical office for the TGA’s Medical Devices and Product Quality Division. The intended purpose will be determined from statements made by the manufacturer in labeling, instructions, advertising material or other documentation provided with the software.