Class II Guidance on Breast Lesion Documentation Devices
07/28/2003
Federal Register Notice: FDA is classifying the breast lesion documentation system into Class II (special controls) and is making available a guidance entitled Class II Special Controls Guidance Document: Breast Lesion Documentation System. This document describes a means by which breast lesion documentation systems may comply with the requirement of special controls for Class II devices. To download this guidance, click here. To view this notice, click here.
