(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]