[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.1100]

[Page 429-430]
 
                        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 B--Obstetrical and Gynecological Diagnostic Devices
 
Sec. 884.1100  Endometrial brush.

    (a) Identification. An endometrial brush is a device designed to 
remove samples of the endometrium (the mucosal lining of the uterus) by 
brushing its surface. This device is used to study endometrial cytology 
(cells).
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' '' and
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (2) Labeling:
    (i) Indication: Only to evaluate the endometrium, and

[[Page 430]]

    (ii) Contraindications: Pregnancy, history of uterine perforation, 
or a recent cesarean section, and
    (3) Design and testing:
    (i) The sampling component is covered within the vagina, and
    (ii) For adherence of the bristles and brush head.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987; 65 FR 17146, Mar. 31, 2000]