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 can be found in this article from the Regulatory Affairs Professionals Society: https://www.raps.org/news-and-articles/news-articles/2020/8/fda-qualifies-decision-tool-for-breast-reconstruct.

The FDA announcement can be read here: https://www.fda.gov/news-events/press-announcements/fda-updates-analysis-medical-device-reports-breast-implant-illness-and-breast-implant-associated