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.
21 CFR Part 814 · Premarket Approval of Medical Devices
§ 814.108 Supplemental applications
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
FDA guidance that cites § 814.108
- Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff 29 May 2026
- Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration Staff 3 Feb 2026
- Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff draft 27 Oct 2025
- Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration Staff 26 Nov 2024
- Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration Staff 2 Nov 2023
- Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Guidance for Industry and Food and Drug Administration Staff 15 Sept 2023
- 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff 16 Dec 2019
- Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff 6 Sept 2019
- Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff 17 Dec 2018
- Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for Industry 13 Jun 2018
Amendment history
Federal Register documents that created or amended this section.
- 63 FR 59220 3 Nov 1998