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
Applications for several surgical masks and a pelvic organ tissue anchoring system, considered at ACMD 61, had been withdrawn.
Applications for a non-surgical shunt device and a knee modular system, considered at ACMD 62, had been withdrawn. Applications for a carbon dioxide injector and a spinal implant device, also from ACMD 62, were approved.
Applications for a femoral reconstruction system, a mesh tape used in orthopaedic surgery and a hip replacement system considered at ACMD 63 were approved, whilst an application for a tissue mesh device intended for use in breast reconstruction surgery was withdrawn.
Applications for an aortic pump designed for long-duration circulatory support and a drug coated balloon catheter to treat urethral strictures, considered in ACMD 64, were both approved. Applications for a hip joint reconstruction system, a breast implant and a continuous glucose monitoring system from ACMD 64 were withdrawn whilst an application for an implantable contact lens was rejected.
There were no other decisions made for items previously considered by the committee.
Overview of the medical devices referred for advice
At the 67 ACMD meeting the committee considered the following devices:
- A knee replacement system
- A cardiac pacing lead
- A wound spray
- Two surgical mesh products
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.
Further 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 #67, one member advised that they had recently attended an educational event that had been arranged and funded by a medical device company, none of whose products were before the committee for advice. The committee considered this did not represent a real or perceived conflict for this member; the member participated fully in the meeting.
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 email acmd.secretariat@health.gov.au.