PART IV INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR MANUFACTURE OF MEDICAL DEVICES WHICH DOES NOT HAVE PREDICATE DEVICE (a) Data to be submitted along with the application (for medical devices other than new in vitro diagnostic):— 1. Design Analysis data including, (whichever applicable)— (a) design input and design output documents; (b) mechanical and electrical tests; (c) reliability tests; (d) validation of software relating to the function of the device; (e) any performance tests; (f) in vitro tests.