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 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 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
The TGA advised:
- a cardiovascular sealant was considered at ACMD 46, the application was approved;
- a spinal decompression spacer was considered at ACMD 48, the application was approved;
- a coronary angioplasty catheter was considered at ACMD 51; the application was approved;
- a balloon catheter was considered at ACMD 51, the application was withdrawn; and
- a device to treat skin cancers was considered at ACMD 56, the application was approved with conditions.
Overview of the medical devices referred for advice
At the 59th ACMD meeting the committee considered the following devices:
- An application for an intraocular lens implant;
- An application for a device to treat pancreatic cancers;
- An application for a self-expanding occlusion device for heart defects; and
- Two currently marketed hip replacement systems.
The committee considered whether the benefits outweighed the risks for the devices and whether adequate evidence was provided to demonstrate safety and performance through compliance with the Essential Principles.
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 Secretariat by phone on 02 6289 6880 or email: acmd.secretariat@health.gov.au.