Australia Issues New Guidance on AIMD and MLMD

On May 9th, 2024, Australia’s Therapeutic Goods Administration (TGA) updated its guidance for AI Medical Devices and Machine Learning Medical Devices. Regulatory systems around the world struggle with applying regulatory structure to software due to its unique characteristics. Any guidance that helps bridge the gap between bureaucratic regulations and innovative devices is welcome information.

The U.S. FDA has also been making updates to its AI/ML (Artificial Intelligence/Machine Learning) Authorized Medical Devices List with the latest update occurring on May 13th, 2024 wherein 191 new Enabled Devices were added. Both the TGA and the FDA are regulatory bodies with much international credibility and therefore can be expected to set the standards for Artificial Intelligence Medical Devices (AIMD) and Machine Learning-enabled Medical Devices (MLMD) which are under the Software as a Medical Device (SAMD) umbrella. This TGA guidance is useful for understanding what the regulatory process looks like should a qualifying medical device be considered SaMD and make use of Artificial Intelligence or Machine Learning.

When does the TGA consider AI to be a Medical Device?

For the TGA, a Medical Devices can encompass an app, website, program, internet service or package and could be on a watch, phone, tablet, laptop, or part of the hardware of a medical device. The point at which AI would typically by considered a Medical Device is if its intended use is for:

• diagnosis, prevention, monitoring, prediction, prognosis, or treatment of a disease, injury, or disability
• alleviation of, or compensation for, an injury or disability
• investigation of the anatomy or of a physiological process
• control or support of conception.

Here are two examples that the TGA cites as a Medical Device that uses AI.

• apps that aid in diagnosing melanoma from mobile phone photos,
• analytics in the cloud that predict patient deterioration.

Additionally, the TGA provides a “Is my software regulated?” flowchart.

Generative AI as a Medical Device

Generative AI is a type of Machine Learning that creates content such as text, images, videos, etc., and is often doing so in response to a prompt. Generative AI is still very new overall and has only begun to trickle into the medical device industry, we expect it to be a sizeable regulatory hurdle.