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.