---
kind: "section"
citation: "21 C.F.R. § 884.2990"
title: "21"
number: "884.2990"
heading: "Breast lesion documentation system."
url: "https://uscodex.org/cfr/21/884.2990"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 884.9](/cfr/21/884.9.md). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See [§ 884.1(e)](/cfr/21/884.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

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