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 device used to treat peripheral vessel haemorrhages (considered at ACMD 88) was approved.
- An application for a transcatheter heart valve (considered at ACMD 89) was withdrawn.
- An application for an ankle implant (considered at ACMD 89) was withdrawn.
- An application for a mechanical heart valve (considered at ACMD 90) was 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 91st ACMD meeting, the committee considered the following items:
- A laser device used to treat prostate cancer.
The committee assessed whether the benefits outweighed the risks for this device and whether sufficient evidence had been provided to demonstrate safety and performance, in accordance with the Essential Principles.
The committee discussed a Summary of Advice for artificial intelligence software for treating patients, which was considered at ACMD 90 and out-of-session.
The committee also provided clinician and consumer input into a planned consultation regarding regulatory pathways for innovative medical devices.
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 #91, a specialist advisor disclosed that they use a competitor product of the laser device used to treat prostate cancer. It was agreed this reflected current clinical practice in the relevant field, as was to be expected, and did not represent an unmanageable conflict of interest.
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.