21 CFR 814.110 - New indications for use.

Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

View all text of Subpart H [§ 814.100 - § 814.126]

§ 814.110 - New indications for use.

(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

source: 51 FR 26364, July 22, 1986, unless otherwise noted.

cite as: 21 CFR 814.110