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
- An application for a spinal cord stimulator (considered at ACMD 78) has been approved.
- An application for a spinal fixation system (considered at ACMD 83) has been approved.
- An application for a catheter surgical kit (considered at ACMD 84) has been approved.
- An application for a heart valve replacement system (considered at ACMD 85) has been approved.
No other decisions have been made recently for items previously considered by the committee.
Medical devices referred for advice
At the 87th ACMD meeting, the committee considered the following items:
- A permanent cardiac implant.
- A glucose monitoring device.
- A device for minimally invasive surgery in the small intestine.
- A breast imaging device.
- An application to extend dermal filler use to the décolleté area.
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 before and during meetings, as appropriate.
Contact
Meeting statements are made publicly available after each meeting. For more information contact the ACMD Secretariat by email TGAMedicalDevices@health.gov.au.