Summary
Date: 4 December 2019
The RACGP thanks the Therapeutic Goods Administration for the opportunity to comment on the 2019 Review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in Australia.
The RACGP supports the re-introduction of the Excluded Purposes Specification 2010 in order to exclude certain self-testing kits for home use. Comment is made on the following points: the seriousness of the disease; test sensitivity, specificity and costs; harms associated with overdiagnosis; benefits of self testing; and governance.