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

Regulations (MQSA)

The FDA issued a Final Rule to Amend the MQSA Regulations ("2023 MQSA Final Rule") on March 10, 2023. Facilities subject to the MQSA and its implementing regulations must comply with all the requirements, including the breast density notification, as of September 10, 2024. The information on this web page has been updated further to conform to the amended MQSA regulations, which are now in effect.

About Regulations

The small entity compliance guidance interprets the MQSA and its implementing regulations, addressing compliance issues and helps facilities meet these requirements. While the guidance is designed to assist facilities in complying with the MQSA and its implementing regulations, it does not have the force of law. Facilities following the guidance developed for a specific MQSA requirement will be considered to have met that requirement. However, as guidance is intended to guide, not mandate, facilities may identify other ways of meeting MQSA requirements.

In contrast, the implementing regulations for the MQSA establish federal quality standards for mammography services. Written by the FDA, and based on the MQSA of 1992 and MQSA Reauthorization of 1998, these regulations have the force of law. Terms such as "shall," "must," and "require" are used to indicate statutory or regulatory requirements.

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