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ACMD meeting statement, Meeting 43, 11 October 2018

7 November 2018

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

A lung tissue ablation system, considered at ACMD 39, was included in the ARTG. Some additional conditions that are related to reporting adverse events were imposed.

There were no other TGA decisions made for items previously considered by the committee.

Overview of the medical devices referred for advice

At the 43rd ACMD meeting the committee considered the following devices:

  • A nasal aspirator;
  • A femoral stem;
  • A cardiac ablation catheter;
  • An acetabular cup, liner and femoral head system;
  • A hyperbaric chamber.

Overview of the post market issues referred for advice

At the 43rd ACMD meeting the committee considered the following post market issues:

  • Safety and performance of two devices intended to treat choking;
  • Safety and performance of an electrosurgical unit; and
  • Clinical evidence requirements for the class of products known as spinal cages.

The committee considered whether the benefits outweighed the risks for the devices and whether adequate evidence has been provided to demonstrate safety and performance through compliance with the Essential Principles.

Further information

Meeting statements are made publicly available after each meeting.

For further information on the ACMD, please visit the ACMD web page or contact the ACMD Secretariat by phone on (02) 6232 8665 or email: acmd@tga.com.au.