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  4. Regulations (MQSA)
  1. Mammography Quality Standards Act and Program

Regulations (MQSA)

On March 10, 2023, the FDA issued the Final Rule to Amend the MQSA Regulations. These updated requirements are to be implemented within 18 months after publication in the Federal Register. As noted in the final rule, the FDA concluded that 18 months was a practical timeframe for facilities to implement these requirements without undue hardship. Facilities are not precluded from including the required breast density notification prior to 18 months; however, facilities subject to MQSA must comply with all the requirements, including the breast density notification, no later than September 10, 2024. The information on this webpage will be updated further when the amended MQSA regulations go into effect.

About Regulations

MQSA guidance interprets MQSA regulations and addresses compliance issues. It is meant to help facilities comply with MQSA Final Regulations, but it does not have the force of law. If facilities follow the guidance developed for a specific MQSA requirement, they will be considered to have met the requirement. However, as guidance is intended to guide, not mandate, facilities may identify other ways of meeting MQSA requirements.

In contrast, the MQSA final regulations are national quality standards for mammography services. Written by FDA, these regulations are based on MQSA of 1992 and MQSA Reauthorization of 1998. They have the force of law. Words such as "shall," "must," and "require" are used when stating statutory or regulatory requirements.

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