August 2024 KD&A Blog – Navigating the Updates to TGA Guidance on Excluded Software and Essential Principle 13B

In July 2024, the Therapeutic Goods Administration (TGA) released significant updates to their guidance documents on Excluded Software and Essential Principle 13B. These updates aim to assist sponsors, manufacturers, and software developers in understanding and complying with the regulatory framework for software-based medical devices in Australia.

The updated Excluded Software Guidance provides a comprehensive overview of the boundaries between software that is and isn’t regulated by the TGA under the Therapeutic Goods (Excluded Goods) Determination 2018. The guidance details the 15 exclusions and one exemption, covering a wide range of software categories such as consumer health lifecycle tools, telehealth technologies, digital mental health applications, and laboratory information systems. The document offers in-depth criteria and examples to help stakeholders interpret these exclusions and determine whether their software products are subject to TGA regulation.

Key updates include:

• Detailed interpretation of exclusion criteria for various software types.
• Clarifications on the regulation of multiple function software.
• Guidance on assessing software against the definition of a medical device as per the Therapeutic Goods Act 1989.

The updated guidance on Essential Principle 13B addresses the requirements for making the version and build number of medical device software accessible and identifiable to users. This principle, introduced as part of the regulatory changes in February 2021, mandates that all medical device software must meet these requirements by November 2024. The updates emphasize the importance of version and build numbers for traceability throughout the software’s lifecycle, facilitating effective post-market surveillance and ensuring compliance with safety and performance standards.

Key updates include:

• Clarifications on the acceptable forms and locations for displaying version and build numbers.
• Examples of how different types of medical devices, including apps, firmware, and systems with multiple software components, can comply with EP 13B.
• Information on using Unique Device Identifiers (UDI) to meet the requirements of EP 13B.

These updates are crucial for ensuring that stakeholders can effectively navigate the regulatory landscape, maintain compliance, and ensure the safety and efficacy of their software-based medical devices. Understanding and adhering to these revised guidelines will help manufacturers and developers streamline their processes and meet the stringent requirements set forth by the TGA.

More detail can be found in the Excluded software and Essential Principle 13B guidance documents.