Role of the ACMD
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
An application for a nasal sinus implant considered at ACMD 78 has been approved.
An application for a component of a reflux management system considered at ACMD 80 has been withdrawn.
No other decisions have recently been made for items previously considered by the committee.
Overview of the medical devices referred for advice
At the 81st ACMD meeting the committee considered the following devices:
- a shoulder replacement system
- a molecular diagnostic test
- a coronary artery stent
- a defibrillator
- a biological scaffold patch
- a knee replacement system
- a breast implant
The committee also provided advice in relation to electronic instructions for use.
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.
Conflict of interest management
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 #81, one committee member indicated a potential conflict of interest, declaring a past professional relationship between a family member and the sponsor of one of the devices 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.
Another committee member declared that the sponsor of one of the devices that the committee had been asked for advice on is an industry partner in a company for which the member is a director. This represented a real or perceived conflict for this member, and the member was excluded from the discussion on that item.
Another committee member declared that they had previously provided advice on testing to the sponsor of one of the devices 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.
A specialist adviser declared that they currently use some medical devices from the manufacturer of one of the devices that the committee had been asked for advice on. The specialist adviser cleared that they do not receive any monetary or other benefit from this manufacturer. The Committee accepted no real conflict existed.
Meeting statements are made publicly available after each meeting.
For more information see Advisory Committee on Medical Devices (ACMD) or contact the ACMD Secretariat by email TGAMedicalDevices@health.gov.au.