[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.110]

[Page 134]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents
 
                   Subpart H--Humanitarian Use Devices
 
Sec. 814.110  New indications for use.

    (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 Sec. 814.102 and shall submit an original HDE in 
accordance with Sec. 814.104.
    (b) An application for a new indication for use made under 
Sec. 814.104 may incorporate by reference any information or data 
previously submitted to the agency under an HDE.