Response to the TGA 2019 Review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in Australia


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.


Read the response

RACGP response to TGA on self testing IVDs (PDF 196 KB)

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