# 21 C.F.R. § 814.110 (2026): New indications for use

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_110

## Section

- **Citation:** 21 C.F.R. § 814.110 (2026)
- **Heading:** New indications for use
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 814: PREMARKET APPROVAL OF MEDICAL DEVICES / Subpart H: Humanitarian Use Devices / § 814.110: § 814.110   New indications for use.

## 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.

## Nearby sections

- [21 C.F.R. § 814.100 (2026) § 814.100   Purpose and scope.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_100.md)
- [21 C.F.R. § 814.102 (2026) § 814.102   Designation of HUD status.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_102.md)
- [21 C.F.R. § 814.104 (2026) § 814.104   Original applications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_104.md)
- [21 C.F.R. § 814.106 (2026) § 814.106   HDE amendments and resubmitted HDE's.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_106.md)
- [21 C.F.R. § 814.108 (2026) § 814.108   Supplemental applications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_108.md)
- [21 C.F.R. § 814.110 (2026) § 814.110   New indications for use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_110.md)
- [21 C.F.R. § 814.112 (2026) § 814.112   Filing an HDE.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_112.md)
- [21 C.F.R. § 814.114 (2026) § 814.114   Timeframes for reviewing an HDE.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_114.md)
- [21 C.F.R. § 814.116 (2026) § 814.116   Procedures for review of an HDE.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_116.md)
- [21 C.F.R. § 814.118 (2026) § 814.118   Denial of approval or withdrawal of approval of an HDE.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_118.md)
- [21 C.F.R. § 814.120 (2026) § 814.120   Temporary suspension of approval of an HDE.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_120.md)
- [21 C.F.R. § 814.122 (2026) § 814.122   Confidentiality of data and information.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_122.md)
- [21 C.F.R. § 814.124 (2026) § 814.124   Institutional Review Board requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_124.md)
- [21 C.F.R. § 814.126 (2026) § 814.126   Postapproval requirements and reports.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_126.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_110. Check the current official text before relying on it. Not legal advice.