Proposed instructions for use or electronic instructions for use and labels.] (b) Data to be submitted along with the application (for new in vitro diagnostic medical devices):— 1. Device data including, (whichever applicable)— (i) design input, design output documents, stability data; (ii) device specification including specificity, sensitivity, reproducibility and reputability; (iii) product validation and software validation relating to the function of the device (if any); (iv) performance evaluation report from a laboratory designated under sub-rule (1) of rule 19. 2. Risk Management data. 3. Clinical Performance Evaluation data carried out in India and in other countries (if any). 4. Regulatory status and restriction on use in other countries (if any) where marketed or approved. 48[5. Proposed instructions for use or electronic instructions for use and labels.]