[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.2990]

[Page 456]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884_OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
       Subpart C_Obstetrical and Gynecological Monitoring Devices
 
Sec. 884.2990  Breast lesion documentation system.

    (a) Identification. A breast lesion documentation system is a device 
for use in producing a surface map of the breast as an aid to document 
palpable breast lesions identified during a clinical breast examination.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance entitled ``Class II Special Controls Guidance 
Document: Breast Lesion Documentation System.'' See Sec. 884.1(e) for 
the availability of this guidance document.

[68 FR 44415, Aug. 27, 2003]