(a) An applicant seeking a new indication for use of a HUD approved under this subpart H shall obtain a new designation of HUD status in accordance with Sec. 814.102 and shall submit an original HDE in accordance with Sec. 814.104.
(b) An application for a new indication for use made under Sec. 814.104 may incorporate by reference any information or data previously submitted to the agency under an HDE.