# 21 C.F.R. § 814.108 (2026): Supplemental applications

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_108

## Section

- **Citation:** 21 C.F.R. § 814.108 (2026)
- **Heading:** Supplemental applications
- **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 / § 814.108: § 814.108   Supplemental applications.

## Text

After FDA approval of an original HDE, an applicant shall submit supplements in accordance with the requirements for PMA's under § 814.39, except that a request for a new indication for use of a HUD shall comply with requirements set forth in § 814.110. The timeframes for review of, and FDA action on, an HDE supplement are the same as those provided in § 814.114 for an HDE.
[63 FR 59220, Nov. 3, 1998]

## 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)

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_108. Check the current official text before relying on it. Not legal advice.