eCFR Reference Browser

---

title: "21 CFR §884.1100"

source: "https://www.ecfr.gov/current/title-21/section-884.1100"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "884"

part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"

subpart_code: "B"

subpart_subject: "Obstetrical and Gynecological Diagnostic Devices"

section_number: "884.1100"

section_subject: "Endometrial brush."

cfr_reference: "21 CFR 884.1100"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§884.1100 - Endometrial brush.