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
- An application for a device that uses infrared light to treat eye problems considered at ACMD 69 was withdrawn.
Overview of the medical devices referred for advice
At the 71st ACMD meeting the committee considered the following devices:
- Patient matched (3D printed) spinal fusion devices used in the neck and lumbar spine
- An ablation catheter used to treat heart arrythmia
- Acetabular components of hip replacement systems
- Femoral components of a hip replacement systems from two separate manufacturers
- A component of a shoulder replacement system
- A capsule for detecting bleeding in the stomach and small intestine
- A knee replacement system for use where there is significant bone loss
- A transcatheter heart valve making claims for new indications
- A transcatheter heart value
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 #71, two Committee members indicated a potential conflict of interest. The committee carefully discussed the potential conflict and chose to proceed with those members excluded from discussion on the relevant items.
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.