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 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
Five out of six applications for home use foetal dopplers – considered at ACMD 68, have been cancelled.
Application for:
- a surgical mesh used for hernia repair – considered at ACMD 69, has been withdrawn.
- a stent to treat dissection of the aorta – considered at ACMD 70, has been approved.
- a component of a shoulder replacement system – considered at ACMD 71, has been rejected.
- a knee replacement system for use where there is significant bone loss – considered at ACMD 71, has been approved.
- a knee replacement system – considered at ACMD 72, has been withdrawn.
- a spinal fixation system – considered at ACMD 72, has been withdrawn.
- a catheter used to drain fluid from the brain – considered at ACMD 72, has been withdrawn.
- an intracranial artery balloon catheter – considered at ACMD 72, has been approved.
- an intracranial artery stent – considered at ACMD 72, has been approved.
- a blood clotting agent – considered at ACMD 73, has been withdrawn.
- a cosmetic filler – considered at ACMD 73, has been withdrawn.
There were no other decisions made for items previously considered by the committee.
Overview of the medical devices referred for advice
At the 75th ACMD meeting the committee considered the following devices:
- a pulmonary heart valve replacement
- an energy-based vaginal rejuvenation device
- an aortic transcatheter heart valve replacement
- an implantable cardiac electronic device
- a cardiac pacing system
- a shoulder replacement system
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.
More 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 #75, one member declared a conflict of interest as a Clinical Proctor, member of steering committee and having prior involvement on an Advisory Board for a Sponsor of a device that the committee had been asked for advice on. This represented a real or perceived conflict for this member, and the member was excluded from the discussion on that item.
Meeting statements are made publicly available after each meeting.
For more information visit the Advisory Committee on Medical Devices (ACMD) webpage or contact the ACMD Secretariat by email TGAMedicalDevices@health.gov.au.