BIO-COMPATIBILITY AND ANIMAL PERFORMANCE STUDY FOR INVESTIGATIONAL MEDICAL DEVICE 1. Recent version of ISO-10993, Biological Evaluation of Medical Devices shall be followed for conducting bio-compatibility study for invasive medical devices. A report of bio-compatibility study along with rationale for selecting specific tests carried out should be prepared including conclusion of the study. 2. Depending on the nature and intended use of investigational medical device, device performance for its actions (including mechanical, electrical, thermal, radiation and any other of this type) and safety shall be assessed in healthy or diseased animal model (intended to be treated by such medical device), as appropriate, demonstrating reaction to active and basic parts of the devices on absolute tissue, local tissue as well as whole organ, clearly recording local, general and systemic adverse reactions, risks or potential risks and performance of device in line with intended use. Wherever possible, histopathology, pathophysiology and path anatomy shall be carried out.Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. 3. If the active component of device is a drug, data for its animal studies as per Schedule Y of the Drugs and Cosmetics Rules, 1945 should be submitted.