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Submissions received: Scope of regulated software based medical devices

15 June 2020

The TGA thanks respondents who provided a submission in response to the public consultation paper, Scope of Regulated Software based products, which closed on 13 May 2020.

This consultation occurred following feedback we received from public and targeted consultation undertaken in during 2019 and early 2020, specifically on clarifying the boundary for software based medical devices that are, in law, regulated under the Therapeutic Goods Act 1989, but could potentially be exempt or excluded (ie: "carved-out") to ensure that industry sponsors and manufacturers are not subject to unnecessary regulatory burden.

We invited respondents to provide feedback on whether there were instances where the software based medical devices presents a lower risk to safety or where a device may already be subject to alternative oversight under another regulatory framework that could then inform a potential carve-out.

The consultation paper presented a number of international examples of approaches taken by comparable overseas medical device regulators to identify possible approaches to carving out certain software based medical devices from our regulation.

A total of 48 submissions were received in response to the Scope of Regulated Software based products consultation paper.

Summary of responses

The majority of respondents were supportive of the regulatory scheme and the concept of carve outs to reduce regulatory burden.

A number of submissions made suggestions on how the regulatory scheme could be enhanced or fine-tuned, noting that further clarification was required specifically on definitions and a shared understanding of risk and how it may inform a carve-out. In addition, many respondents whilst supportive of a carve-out also suggested that the TGA continue to play an ongoing monitoring or "stewardship" role of those devices subject to the carve-out. Many indicated that where products impact patient safety and public health safety, these should not have reduced regulatory oversight unless risks are well understood by the users. Patients and clinicians who use the software based medical devices, including apps, must be able to trust the efficacy and accuracy and this needs to be assessed by a trusted entity, independent of the software developers.

There was broad support for clinical decision support systems being included in a carve‑out scheme – however there were some differences as to whether there should be certain conditions under which these systems should be carved-out. Several respondents noted that all clinical decision support systems should be carved-out as health professionals exercise appropriate responsibility and there was some industry based requirements already used to guide development of such systems. A total carve-out of these systems may, however be inconsistent with the regulatory approach in other countries.

Other respondents advised that if such clinical decision support systems were not linked to other systems or used machine learning or artificial intelligence – these could become de facto decision makers and may thus still require regulatory oversight.

For direct to consumer software medical devices including apps, respondents noted that consideration should be given to privacy concerns, vulnerable groups, low IT literacy, and the risk of poor outcomes and increased risk of mismanagement as a result of software devices.

Next steps

We will continue to analyse the feedback received and use the information to guide further targeted discussions to refine a proposal to be developed for future consideration by the Government. Any proposed carve-out will need to broadly align (where possible) with those in other countries, although there are differences between the approaches taken for carve-outs between countries.

Submissions received

All submissions that gave permission to be published on the TGA website are available below in PDF format.

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