> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Academics Urge FDA to Simplify Breast Density Notifications
- URL: https://www.fdaweb.com/academics-urge-fda-to-simplify-breast-density-notifications/
- Published: 2022-12-12T12:00:00.000Z
- Updated: 2026-09-14T18:09:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153372

A 12/12 *JAMA* [viewpoint article](https://jamanetwork.com/journals/jama/fullarticle/2799677?ref=fdaweb.com) is urging FDA to appropriately test for readability and general literacy its breast density notification language that is part of an upcoming rule that was mandated by the 2019 Breast Density and Mammography Reporting Act. The rule would require providers to include mandatory statements accompanying mammographic results that tell women whether they have dense breasts, what this means for their risk of breast cancer, and the importance of speaking with a healthcare provider about breast density.

Authored by Boston University’s **Nancy R. Kressin** and **Priscilla J. Slanetz**, and Dartmouth’s **Christine M. Gunn,** the article says that based on their research, FDA’s proposed notifications are “not likely to be understandable to all women in the general population, as most proposed notifications from states and the FDA exceed the general literacy level of women in the population and the recommended eighth-grade reading level (FDA’s own best practice requirement).”

The authors recommend that FDA “learn from the published literature detailing women’s experience with states’ density notification laws, which has revealed a wide range of responses.” They are say FDA should rigorously test its languages similarly to the testing conducted to notify the public about the harms of cigarette smoking. “Similarly,” they add, “the FDA must invest resources to ensure that women’s reactions to the breast density notification language will lead to the intended outcomes of increased awareness and knowledge regarding breast density and informative conversations with health care clinicians about personal risk and the appropriateness of supplemental screening.”

In October, Rep. **Rosa DeLauro** (D-CT) said she had been informed by FDA that the new breast density notification rule is to be published by the end of 2022 or early in 2023 ([see earlier story](https://www.fdaweb.com/breast-density-notification-rule-due-soon-delauro/)).