Consultation: Clarification of how Clinical Decision Support System (CDSS) software is regulated

About this consultation

In February 2021, the TGA made changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) to clarify regulatory requirements for software-based medical devices. These changes included a conditional exemption for certain low-risk CDSS software medical devices. 

The TGA has received sector concerns about the exemption including the:

• term ‘clinical decision support’ is used inconsistently, causing confusion among some users
• incorrect application of the conditional exemption to in vitro diagnostic medical devices
• performance of CDSS products may be challenging to verify at the time of use, potentially increasing risk for patients and clinicians
• prevalence of software products falsely claiming to be exempt CDSS products, leading to an unacceptable increase in patient risk.

This consultation aimed to gather feedback on appropriateness of current CDSS regulation including exemption criteria, definitions of CDSS and whether the regulatory requirements were clear.

Outcome of the consultation

A total of thirty-five (35) responses were received from industry, health professionals and consumers. Additional targeted discussions were held with representatives from commonwealth, state and territory government departments. 

We have published a summary of responses on the TGA Consultation Hub, alongside individual responses where consent was obtained from the respondent.

Next steps

Feedback will be used to inform policy decisions made by the Australian Government regarding the regulation of exempt CDSS products.

Enquiries

For any enquiries relating to this consultation or next steps, please contact emergingtechnology@health.gov.au.