21 CFR § 814.108 - Supplemental applications.

---
identifier: "/us/cfr/t21/s814.108"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 814.108 - Supplemental applications."
title_number: 21
title_name: "Food and Drugs"
section_number: "814.108"
section_name: "Supplemental applications."
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"
---


# 814.108 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, 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]