Document ID: chunk:federal_register_of_legislation:F2024C00750:reg:14a
Version: federal_register_of_legislation:F2024C00750
Segment Type: reg
Provision Reference: reg 14A
Character Range: 9429–10169

14A              software that is:
                 (a) intended by its manufacturer to be used by a consumer for the self-management of an existing disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect; and
                 (b) not intended by its manufacturer to be used:
                        (i) in clinical practice; or
                        (ii) in relation to a serious disease or serious condition, ailment or defect; or
                        (iii) for the purpose of diagnosis, treatment, or making a specific recommendation or decision about the treatment, of a disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect