[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.400]

[Page 584]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35_MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                     Subpart F_ Manual Brachytherapy
 
Sec. 35.400  Use of sources for manual brachytherapy.


    A licensee shall use only brachytherapy sources for therapeutic 
medical uses:
    (a) As approved in the Sealed Source and Device Registry; or
    (b) In research in accordance with an active Investigational Device 
Exemption (IDE) application accepted by the FDA provided the 
requirements of Sec. 35.49(a) are met.