Role of the ACMD
The Advisory Committee on Medical Devices (ACMD) is a statutory advisory committee established by the Therapeutic Goods Regulations 1990.
The committee provides independent expert advice on specific scientific and technical matters to aid the TGA's decision making and other regulatory processes.
While the advice provided by the ACMD is an important element in the undertaking of the TGA's regulatory functions, it forms only part of the information that is available to delegates when they make a regulatory decision 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
- An application for a surgical mesh used for breast surgery (considered at ACMD 70) has been withdrawn
- An application for a heart ablation catheter (considered at ACMD 79) has been withdrawn
- An application for a molecular diagnostic test (considered at ACMD 81) has been rejected
- An application for a biological scaffold patch (considered at ACMD 81) has been withdrawn
- An application for a breast implant (considered at ACMD 81) has been withdrawn
No other decisions have been made recently for items previously considered by the committee.
Overview of the medical devices referred for advice
At the 82nd ACMD meeting, the committee considered the following devices:
- A defibrillator
- A coronary artery stent
- Two knee replacement systems
- Two shoulder replacement systems
The committee also provided advice regarding a clinical trial.
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 #82, one committee member declared a potential conflict of interest, noting that they had previously provided advice on testing to the sponsor of one of the devices under consideration. This represented a real or perceived conflict of interest, and the member was excluded from the discussion of that item.
Contact
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.