Note: This meeting extract has been prepared from the ratified record of the NCCTG IVD Working Group meeting held 27 March 2002.

Preamble

The principal goals of the meeting were to review the pillars of a regulatory framework, to develop assessment criteria for the proposal, and to begin work on determining a suitable classification system for IVDs in Australia.

Meeting discussions

The meeting record from the 21 February 2002 meeting was ratified by the Working Group.

A draft survey to be sent to a select group of representative laboratories, to investigate the use of small volume tests was amended following discussions by the Working Group. A list of appropriate laboratory respondents was forwarded to the Working Group secretariat.

A TGA Adviser gave a presentation on the pillars of a regulatory framework, namely risk classification, standards, audit/licensing, a product register and post-market surveillance; and the Working Group discussed the importance of each of these pillars with respect to IVDs.

The Working Group participated in two (2) facilitated exercises during the course of the meeting:

• to develop a set of criteria against which the success of the resulting regulatory proposal from the Working Group, could be measured, thereby ensuring that it is sound, and
• to determine the best risk classification system for IVDs in Australia

The latter exercise involved isolating mandatory and desirable criteria for a suitable classification system, and then developing a list of possible classification options.

The following topics were also discussed:

• risk evaluation for IVDs and the need to distinguish between risk to the patient being tested, risk to the user and risk to public health;
• batch release programs in place in other jurisdictions, and the need for a batch release program as part of the regulatory framework for IVDs in Australia

Key outcomes

Outcomes of the meeting included:

• a commitment to send the survey concerning small volume testing by the end of April;
• the need to develop an industry version of the survey, to compare the data collected from test users with that from IVD manufacturers;
• the need to include the option for batch release in the new regulatory framework, so that should regulatory review of individual batch data be needed at any point following approval of a given test, a mechanism exists by which appropriate information can be solicited from the manufacturer, and
• the need to continue the discussion on selecting an appropriate classification system.

Rita Maclachlan
Chair
3 July 2002