21 C.F.R. § 814.110 New indications for use.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
Subpart H—Humanitarian Use Devices
§ 814.110 New indications for use.
