"Off Label" Use of FDA-Approved Devices and Digital Breast Tomosynthesis.
OBJECTIVE
The purpose of this article is to clarify for radiologists the meaning of U.S. Food and Drug Administration (FDA) approval with respect to Digital Breast Tomosynthesis (DBT).


CONCLUSIONS
DBT is a major improvement over 2D mammography in the detection of cancers (sensitivity) and the reduction in recalls resulting from screening (specificity). Most imaging systems that have been approved by the FDA are used "off label" for breast imaging. Although the FDA determines which claims a manufacturer can make for a device, physicians may use approved devices, such as DBT, off label to provide better patient care.
1 Department of Radiology, Breast Imaging Division, Harvard Medical School, Massachusetts General Hospital, Avon Breast Center, Wang Ambulatory Care Center, Ste 240, 55 Fruit St, Boston, MA 02114.
Daniel B
DB
Kopans
D001943:Breast Neoplasms / Q000000981:diagnostic imaging*; D018795:Device Approval; D055088:Early Detection of Cancer; D005260:Female; D006801:Humans; D008327:Mammography; D011856:Radiographic Image Enhancement / Q000379:methods*; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
breast; breast cancer screening; digital breast tomosynthesis; mammography