(b) a pivotal clinical investigation on an investigational medical device shall be made on the basis of data emerging from pilot clinical investigation, accompanied with a fee as specified in the Second Schedule: PROVIDED that no fee shall be payable by any institute, organisation, hospital run or funded by the Central Government or the State Government, as the case may be, for conduct of clinical investigation. (3) No permission for conduct of academic clinical study on licensed medical device shall be required, where, — (a) the Ethics Committee approves such a study; and (b) the data generated during the study shall not be used to furnish to the Central Licensing Authority to manufacture or to import for marketing any investigational medical device in the country. (4) The Central Licensing Authority may, in public interest, abbreviate, defer, or waive the requirement of animal data or clinical data for conducting clinical investigation for reasons to be recorded in writing before granting permission to conduct clinical investigation.