Comments on FDA Proposed Rule on Density Reporting

The open period to provide comments on the FDA’s proposed amendments to the Mammography Quality and Safety Act (MQSA) ended June 26, 2019 and DB-I’s comment letter on the breast density reporting section of the amendment is posted on our website. We were encouraged to find that comments from a number of other national organizations expressed agreement (see below) with the DB-I recommendations and hope the final rule will reflect this support.

  • The American Cancer Society’s letter stated: “We are aware of recommendations that have been made by, and we think they are sensible.”
  • A group letter from 16 women’s health organizations, including Susan G. Komen, said: “We extend special thanks to for their leadership in the development of the recommended language.”
  • A number of state “inform” advocacy groups supported the DB-I language in their comments. 

What’s Next?

All comments are currently being reviewed and a final rule will be published by the FDA when all submissions have been taken into consideration. The amendment will become effective 18 months following finalization, probably in early 2021. We will keep you posted of any developments.