Regulation Text
(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 § 814.102 and shall submit an original HDE in accordance with § 814.104 .
(b) An application for a new indication for use made under § 814.104 may incorporate by reference any information or data previously submitted to the agency under an HDE.
Authority
21 U.S.C. 351,352,353,360,360c-360j,360bbb-8b,371,372,373,374,375,379,379e,379k-1,381.