FDA MQSA and DB-I Europe Updates

FDA Proposed Rule on Mammography Quality Standards Act (MQSA)

It’s done! After multiple iterations and a great deal of useful input from many of you, DB-I has submitted its comments to the FDA on the proposed MQSA amendment. Though the proposed amendment covers other topics, as the leading expert on density-inform law analysis, DB-I comments (which can be viewed HERE are focused exclusively on the proposed density notification language and implementation.

What’s next? The public comment period for this proposed rule ends on June 26, 2019. All comments will then be reviewed by the FDA and a final rule will be published. The amendment will become effective 18 months following finalization, likely in early 2021.

Prominent International Oncology Resource, ecancer.org, Highlights Importance of Breast Density Education

Our thanks to ecancer.org for highlighting a piece on the importance of breast density education for women and the health care community. The article, Why Breast Density Matters, was authored by Cheryl Cruwys, DB-I’s European Education Coordinator and founder of Breast Density Matters UK, who recently joined the ecancer.org editorial board.