TGA Proposes New IVD Device Regulations

Australia’s Therapeutic Goods Administration outlines a proposed new regulatory framework for in vitro diagnostic devices in a new consultation paper.

The proposal would make 10 key alterations to current agency regulations of IVD devices. The proposed amendments range from requiring unique product identifiers for all IVD companion diagnostics in applications for inclusion on the Australian Register of Therapeutic Goods to a proposal to require a compulsory audit of all IVD companion diagnostics before inclusion on the ARTG.

The proposals are primarily based on other international agencies such as the FDA and European Medicines Agency’s IVD companion diagnostics regulations, and are the TGA’s response to increased use of precision medicine and continual efforts to harmonize international regulations.

The consultation paper addresses the definition of a device, which currently has no clear definition under Australian regulations, and proposes to follow the FDA’s model by clarifying the definition through guidance rather than regulation, allowing the agency to amend or update the definition as needed in case of unintended interpretations.

The FDA uses the term “complementary diagnostics” to refer to those IVDs that are considered to aid in the benefit-risk decision-making about the use of a medicine in a clinically meaningful way. TGA is not currently proposing to adopt this terminology.

Read the paper here: www.fdanews.com/10-25-18-TGA.pdf. — Zack Budryk