Reed Smith Client Alerts

The Food and Drug Administration (FDA) has issued new final rules aimed at modernizing mammography regulations. These rules, which were first proposed in March 2019, seek to improve the quality and accuracy of mammograms and ensure that patients have access to high-quality mammography services. The final rules have several significant revisions from the proposed rule, including changes in terminology and clarifications on various requirements. The new rules take effect September 10, 2024.

As described more fully below, FDA’s final rule, when effective, will require screening mammography providers nationwide to notify patients – in reports written in “lay language” – whether they have dense breasts and to encourage patients to discuss their risk of cancer with their health care provider.

One significant change is the substitution of the term “provider” or “healthcare provider” in place of references to “referring physician” in several paragraphs. This change reflects the reality that mammography is often ordered by a variety of health care professionals and not just physicians.

Another significant revision is the requirement that no accrediting body shall accept an application for accreditation from a facility that has had three consecutive failures to become accredited until one year after the most recent accreditation failure. This change is intended to ensure that facilities are held accountable for providing high-quality mammography services.

Additionally, facilities must now retain personnel qualification records of former employees for at least 24 months. This change is aimed at improving accountability and ensuring that personnel who are no longer employed at a facility are not able to perform mammography services elsewhere without proper qualifications. Similar to the treatment of medical records, a facility that closes or ceases to provide mammography services must make personnel records available by transferring the records to another facility or to the personnel.

The proposed term “digital accessory components” has been removed, and premarket requirements for devices used in mammography have been clarified, including a requirement that all devices used in mammography meet the applicable FDA premarket authorization requirements. This change is aimed at ensuring that devices used in mammography meet high-quality standards and that patients receive accurate and reliable results.