GroundRules
21 CFR 814.110: New indications for use.
Where this section sits in the code
- 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
(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.
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON