21 CFR § 814.110 - New indications for use.

---
identifier: "/us/cfr/t21/s814.110"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 814.110 - New indications for use."
title_number: 21
title_name: "Food and Drugs"
section_number: "814.110"
section_name: "New indications for use."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "814"
part_name: "PREMARKET APPROVAL OF MEDICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381."
regulatory_source: "51 FR 26364, July 22, 1986, unless otherwise noted."
cfr_part: "814"
---


# 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.