21 CFR 884.1100
§ 884.1100 Endometrial brush.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 884.1100, § 884.1100 Endometrial brush, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90780
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Full text
(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
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.