Role of the ACMD in the TGA's regulatory decision making process
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 in order 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 appropriate consideration will always be given to such advice, the TGA is not obliged to follow the specific recommendations and advice given by the committee.
It should also be noted that information about advice provided by the committee may not become publicly available for some time after the committee has provided that advice. The purpose of this Meeting Statement is to describe in general terms the matters considered by the committee at each meeting and for it to be available as soon as reasonably practical after the relevant meeting.
Update on matters where the committee previously provided advice and a TGA decision has been made
- Applications for two knee replacement systems considered at ACMD 68 were approved
- A knee replacement system considered at ACMD 67 was withdrawn
- Two surgical mesh products considered at ACMD 67 were approved
- Applications for two devices considered at ACMD 66 – a shoulder replacement system and a device for treating sleep apnoea - were withdrawn
- An application for a femoral reconstruction system considered at ACMD 64 was withdrawn
- Applications for two devices - a bone and soft tissue filler that can be used with infections and a revision knee replacement system considered ACMD 65 were approved
Overview of the medical devices referred for advice
At the 70th ACMD meeting the committee considered the following devices:
- Four shoulder replacement systems
- A hip replacement system
- A gel for use with implanted devices to prevent infection
- A knee replacement system
- A surgical mesh used for breast surgery
- A stent to treat dissection of the aorta
- A Transcatheter Valve Replacement system
- A gaze tracking assessment system
- A device to deliver medicine to the eye
The committee considered whether the benefits outweighed the risks for the devices and whether adequate evidence had been provided to demonstrate safety and performance through compliance with the Essential Principles.
Further information
Consideration and management of declarations of actual or potential conflicts of interest by committee members occurs by the Chair, committee members and the Department prior to and during the meeting (as appropriate).
For meeting #70, an invited expert adviser indicated a potential conflict of interest relating to the provision of advice for a fee to the manufacturer of a medicine used with a device being discussed by the committee. The manufacturer who provided the fee was different to the manufacture of the device. The committee carefully discussed the potential conflict and chose to proceed with the adviser excluded from discussion regarding TGA’s final advice
Meeting statements are made publicly available after each meeting.
For further information on the ACMD, please visit the ACMD Webpage or contact the ACMD Secretariat by email acmd.secretariat@health.gov.au.