[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: 21CFR814.108]

[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. 814.108  Supplemental applications.

    After FDA approval of an original HDE, an applicant shall submit 
supplements in accordance with the requirements for PMA's under 
Sec. 814.39, except that a request for a new indication for use of a HUD 
shall comply with requirements set forth in Sec. 814.110. The timeframes 
for review of, and FDA action on, an HDE supplement are the same as 
those provided in Sec. 814.114 for an HDE.

[63 FR 59220, Nov. 3, 1998]