21 CFR § 884.2990 - Breast lesion documentation system.

---
identifier: "/us/cfr/t21/s884.2990"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.2990 - Breast lesion documentation system."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.2990"
section_name: "Breast lesion documentation system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "884"
part_name: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "45 FR 12684, Feb. 26, 1980, unless otherwise noted."
cfr_part: "884"
---


# 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 device, when it is a breast examination recording sheet, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See § 884.1(e) for the availability of this guidance document.

[68 FR 44415, Aug. 27, 2003, as amended at 84 FR 71816, Dec. 30, 2019]