ACMD meeting statement, Meeting 86, 14 August 2025

Role of the ACMD

The Advisory Committee on Medical Devices (ACMD) is a statutory advisory committee established under the Therapeutic Goods Regulations 1990. The committee provides independent expert advice on specific scientific and technical matters to support the TGA's decision-making and regulatory processes.

While the advice provided by the ACMD is an important component of the TGA's regulatory functions, it is only part of the information considered by delegates when making decisions under the Therapeutic Goods Act 1989.

It is important to note that while the TGA gives appropriate consideration to ACMD advice, it is not obliged to follow the committee's recommendations. Additionally, information about the advice provided by the committee may not become publicly available.

The purpose of this meeting statement is to outline, in general terms, the matters considered by the committee at each meeting. The statement is made publicly available as soon as reasonably practicable after the relevant meeting.

Update on matters where the committee previously provided advice and a TGA decision has been made

• An application for a mesh device used for breast surgery (considered at ACMD 70) has been approved subject to conditions.
• An application for a radiological image processing application surgery (considered at ACMD 85) has been approved.
• An application for a knee replacement system (considered at ACMD 82) has been approved.
• An application for a surgical aortic heart valve replacement (considered at ACMD 83) has been approved.

No other decisions have been made recently for items previously considered by the committee.

Overview of the medical devices referred for advice

At the 86th ACMD meeting, the committee considered the following devices:

• An artificial intelligence-based aid for radiological diagnosis.
• A hip prosthesis.
• An artificial intelligence support tool for interpretation of anatomical pathology specimens.

The committee assessed whether the benefits outweighed the risks for these devices and whether sufficient evidence had been provided to demonstrate their safety and performance, in accordance with the Essential Principles.

The committee also provided their views regarding Clinical Treatment of Mitral Regurgitation in Australia.

Conflict of Interest Management

Declarations of actual or potential conflicts of interest by committee members are managed by the Chair, committee members, and the Department, both prior to and during meetings, as appropriate.

At Meeting #86, a committee member disclosed that their employer is a subsidiary of the sponsor associated with one of the applications under review. This disclosure constituted a real or perceived conflict of interest. As a result, the member was excluded from all discussions and deliberations related to that item.

More Information

Meeting statements are made publicly available after each meeting.

For more information see Advisory Committee on Medical Devices (ACMD) or contact the ACMD Secretariat by email TGAMedicalDevices@health.gov.au.