 |
Code of Federal Regulations (Last Updated: May 6, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
SubChapter H - Medical Devices |
|
Part 814 - Premarket Approval of Medical Devices |
|
Subpart H - Humanitarian Use Devices |
§ 814.108 - Supplemental applications.
Latest version.
-
§ 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]