Federal Register Proposed rule: FDA is proposing to reclassify the full field digital mammography (FFDM) system from Class 3 (premarket approval) to Class 2 (special controls). The device type is intended to produce full field digital x-ray images of the breast. The agency is also releasing a draft guidance document, Class II Special Controls Guidance Document: Full Field Digital Mammography System. To download this guidance, click here. To view this proposed rule, click here.