---
kind: "section"
citation: "21 C.F.R. § 814.108"
title: "21"
number: "814.108"
heading: "Supplemental applications."
url: "https://uscodex.org/cfr/21/814.108"
---

# §814.108. Supplemental applications.


After FDA approval of an original HDE, an applicant shall submit supplements in accordance with the requirements for PMA's under [§ 814.39](/cfr/21/814.39.md), except that a request for a new indication for use of a HUD shall comply with requirements set forth in [§ 814.110](/cfr/21/814.110.md). The timeframes for review of, and FDA action on, an HDE supplement are the same as those provided in [§ 814.114](/cfr/21/814.114.md) for an HDE.


## Notes

### Amendments

[63 FR 59220, Nov. 3, 1998]

### 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.

### Amendments

[63 FR 59220, Nov. 3, 1998]