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 TGA currently has eleven statutory advisory committees from which it can obtain independent expert advice on specific scientific and technical matters to aid the TGA's regulatory decision making and other regulatory processes. The ACMD provides advice to the TGA on, amongst other things, matters relating to medical devices.
The advice provided by the ACMD is an important element in the undertaking of the regulatory functions of the TGA. However, it forms only part of the information that is available to, for instance, a TGA delegate making a regulatory decision under the Therapeutic Goods Act. While appropriate consideration will be given to such advice, it is important to note that neither the TGA nor a TGA delegate is obliged to follow it.
It should also be noted that information about advice provided by the committee may not become publicly available for some time after a 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
The committee received an update on the non-invasive home-use/point-of-care blood glucose analysis system considered at the previous meeting. It was the belief of the committee that the claims of the device were unsubstantiated and the application was still under consideration by the TGA.
It was decided not to issue a conformity assessment certificate for the steroid-eluding endocardial pacing lead considered at the previous meeting.
Overview of the therapeutic goods referred for advice
At the ACMD 26th meeting the committee considered four Class III medical device applications. The devices were:
- An intracardiac pacemaker;
- A vena cava filter;
- A range of biventricular pacemakers, and;
- A range of rate-responsive dual-chamber pacemakers.
The committee considered whether the benefits outweighed the risk for the devices and whether adequate evidence has been provided to demonstrate safety and performance through compliance with the Essential Principles.
The committee's advice has now been provided to the TGA for consideration as part of the TGA's regulatory decision-making processes.
Contact
Meeting statements are made publicly available after each meeting.
For further information on the ACMD, visit the ACMD web page or contact the ACMD Secretary by phone on 02 6232 8216 or email: acmd@tga.com.au.