Document ID: chunk:federal_register_of_legislation:F2024C00750:reg:14k
Version: federal_register_of_legislation:F2024C00750
Segment Type: reg
Provision Reference: reg 14K
Character Range: 14469–15223

14K              software that is middleware and is:
                 (a) intended by its manufacturer to connect or interface applications to an underlying operating system or another application, including by communicating or transmitting information; and
                 (b) not intended by its manufacturer to:
                        (i) control medical devices; or
                        (ii) perform analysis, computation or logic that relates to the intended purpose of a medical device; or
                        (iii) be used for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a disease, condition, ailment or defect