FDA Qualifies the BREAST-Q Reconstruction Module as a Medical Device Development Tool

On August 20, 2020, the U.S. Food and Drug Administration (FDA) announced the qualification of the BREAST-Q Reconstruction Module for breast reconstruction studies through the agency’s Medical Device Development Tool (MDDT) Program. Qualification of the BREAST-Q Reconstruction Module MDDT included the Physical Well-being (Chest), Psychosocial Well-being, Sexual Well-being, and Satisfaction with Breasts scales. More information […]