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 Therapeutic Goods Administration’s (TGA) 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- An application considered at ACMD 68 for an implanted heart attack warning system was withdrawn.
- An application for a knee replacement system considered at ACMD 69 was withdrawn.
- An interventional paediatric catheter and a knee replacement system considered at ACMD 69 were approved.
- Two items considered at ACMD 71 - a spinal fusion cage and a pack containing the cage - were approved.
Overview of the medical devices referred for advice
At the ACMD 72 meeting the Committee considered applications for the following devices:
- A spinal fixation system
- A knee replacement system
- A catheter used to drain fluid from the brain
- An intracranial artery balloon catheter
- An intracranial artery stent
- An absorbable haemostatic agent
- Menstrual cup products
The Committee provided advice on the following marketed devices:
- An ablation catheter used on the heart
- A balloon catheter using sound waves to break calcifications
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. Additionally, the Committee provided advice on the safety of menstrual cup products and their duration of use, as specified in an excluded goods order.
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 #72, no Committee members indicated a potential conflict of interest.
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.