It’s Been A Long Time Coming! Most of the requirements in our MQSA mammography regulations are 20 years old and, in some cases, not reflective of current clinical practice. The updates according to the FDA are to, “modernize the regulations by incorporating current science and mammography best practices”. The changes first proposed in 2019 were published in the federal register for comments. On March 10, 2023, the FDA issued a final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) with an effective date of September 10, 2024. This gives facilities eighteen months to comply with the new and revised regulations.
The FDA summarized the improvements in the regulations into three broad categories:
- Improvements that addresses changes in mammography technology
- Improvements that enhance enforcement of quality standards
- Improvements in the way mammography results are categorized, reported, retained and transferred to patients.
At first glance, the changes don’t appear to be sweeping; however, there are several revisions that enhance enforcement that may require mammography practice policy changes and updates.
The revision that has gotten the most buzz to date is the breast density reporting requirement. The updated regulations codify breast density reporting into the federal law. There are currently only 12 states that have not enacted breast density reporting requirements, so many facilities have been reporting on breast density for many years. So, they will be ahead of the game in this aspect of the regulation updates but will need to make sure the state regulations requirements incorporate all aspects of what is in the federal law. My experience with mammography regulations has been “the devil is in the details,” so stay tuned!
