Since this article was published, there’s been progress on both the federal legislative and the FDA regulatory fronts for national breast density standard (DenseBreast-info).
- In February 2019, the federal law directed the Food and Drug Administration (FDA), through the regulatory process, to develop breast density reporting language for patients and health providers.
- In March 2019, the FDA proposed reporting language updates; next steps would be the publication of the FDA/Mammography Quality Standards Act (MQSA) Final Rule. In the meantime, individual state "inform" laws remain in effect and guide reporting requirements.
- On March 10, 2023, the FDA issued a national requirement for dense breast reporting to patients and their referring providers. All mammography facilities will have to comply by September 10, 2024. Once the rule goes into effect, patients must be sent one of two Federal density notification statements ("not dense" or "dense") and the mammogram report sent to referring providers must include an assessment of the patient's breast density. For more info, click here.
