{"data":{"id":"us/21-cfr-814.110","jurisdiction":"us","citation":"21 CFR 814.110","heading":"New indications for use.","body":"(a) An applicant seeking a new indication for use of a HUD approved under this subpart H shall obtain a new designation of HUD status in accordance with § 814.102 and shall submit an original HDE in accordance with § 814.104.\n(b) An application for a new indication for use made under § 814.104 may incorporate by reference any information or data previously submitted to the agency under 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":"e1f33821c51870aa80a5676e4ca4c0061fe96e8d128800d6c476dfc4cf475112","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-814.108","next":"us/21-cfr-814.112"},"notice":"GroundRules: Original legal text. Not legal advice."}