21 CFR 814.108
§ 814.108 Supplemental applications.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 814.108, § 814.108 Supplemental applications, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88880
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Full 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.