21 C.F.R. § 884.2990

Current through September 30, 2024
Section 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.

21 C.F.R. §884.2990

68 FR 44415, Aug. 27, 2003, as amended at 84 FR 71816, Dec. 30, 2019
As amended at 84 FR 71816, 12/30/2019