---
kind: "section"
citation: "21 C.F.R. § 814.110"
title: "21"
number: "814.110"
heading: "New indications for use."
url: "https://uscodex.org/cfr/21/814.110"
---

# §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](/cfr/21/814.102.md) and shall submit an original HDE in accordance with [§ 814.104](/cfr/21/814.104.md).
- (b) An application for a new indication for use made under [§ 814.104](/cfr/21/814.104.md) may incorporate by reference any information or data previously submitted to the agency under an HDE.

## Notes

### Source

Source: 61 FR 33244, June 26, 1996, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.

### Source

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