TGA guidance for SaMD Regulatory “Carve Out”

Author: Homi Dalal

Following a public consultation on the Regulation of software, including Software as a Medical Device (SaMD) in early 2019, the TGA introduced several regulatory changes, including:

• new classification rules for medical device software-based products (except IVD medical device software); and
• changes to the Essential Principles for safety and performance of software-based medical devices, to improve the clarity of requirements.

Consequent to these changes, the new regulatory framework considers the risk of patient harm where incorrect information is the source of harm. Majority of the new requirements were meant to come into effect from 25 August 2020 with a four-year transition period. However, in consideration of the COVID-19 pandemic, the Australian Government delayed the commencement of a number of medical device reforms. The Australian Medical Device Regulations have now been amended to delay implementation of the following reforms:

• 25 February 2021 for medical device software, personalised medical devices (including 3D printed devices) and systems or procedure packs; and
• 25 November 2021 for reclassification of certain devices.

It is important to note that the delay to the commencement of the reforms does not change the end of the transition period, which remains as at 31 October 2024.

In March 2020, the TGA undertook another public consultation seeking feedback on a proposal to “carve out” from Therapeutic Goods Regulation some low-risk software medical devices, or devices that were subject to other oversight arrangements, such as NPAAC and/or NATA accreditation. Based on an analysis of the feedback received, in August 2020 the TGA published proposed categories of software for Exemption or Exclusion from the regulations.

The TGA is currently in the process of finalising draft instruments to Exempt certain software based on conditional criteria for Clinical Decision Support Systems, and Exclude the following groups of software:

1. Consumer health products – prevention, management and follow up devices that do not provide specific treatment or treatment suggestions;
2. Enabling technology – for telehealth, remote diagnosis, healthcare or dispensing;
3. Digitisation – of paper-based or other published clinical rules or data including simple dose calculators and Electronic Patient Records;
4. Analytics – population-based analytics that do not drive outcomes for individuals, including data analytics; and
5. Laboratory Information Management Systems – including pathology and radiology use cases and software to automate workflows, integrate instruments, manage orders and samples and associated information (given these systems are already subject to oversight through other mechanisms).

To assist sponsors meet their obligations prior to the amended regulations affecting medical device software from 25 February 2021, the TGA is developing a package of guidance materials and fact sheets, including flowcharts and examples, to be published on their website by the year-end 2020.