{"data":{"id":"us/21-cfr-814.108","jurisdiction":"us","citation":"21 CFR 814.108","heading":"Supplemental applications.","body":"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.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"a5b3d37acf6330090a956031f34ba92d75571b1fde791dcbff0f6fe939d65f24","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-814.106","next":"us/21-cfr-814.110"},"notice":"GroundRules: Original legal text. Not legal advice."}