ACMD meeting statement, Meeting 83, 13 February 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 an aortic transcatheter heart valve replacement (considered at ACMD 75) has been approved.
• An application for a cardiac pacing system (considered at ACMD 75) has been approved.
• An application for an implantable cardiac electronic device (considered at ACMD 75) has been approved.
• An application for a knee replacement system (considered at ACMD 81) has been withdrawn.
• An application for a coronary artery stent (considered at ACMD 82) 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 83^rd ACMD meeting, the committee considered the following devices:

• a spinal fixation system
• an artificial intelligence-based device that interprets electrocardiograms
• an artificial intelligence-based device to estimate prognosis and predict treatment benefit
• a software device to detect hepatocellular carcinoma
• a surgical aortic heart valve replacement.

The committee also provided their views on bioprosthetic heart valves.

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.

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.

For meeting #83, one committee member declared that they have a consulting agreement with a sponsor who manufactures heart valves, however, their consulting work is unrelated to the sponsor’s heart valves products. The committee discussed this declaration and accepted no real conflict existed in relation to the devices being assessed at this meeting.

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.