Policy Guidance Help System
The Policy Guidance Help System was last updated October 11, 2017
The Policy Guidance Help System has useful information for mammography facilities and their personnel. It shows the Food and Drug Administration’s (FDA) current view on the final regulations implementing the Mammography Quality Standards Act (MQSA) (Pub. L.102-539). The FDA uses mandatory language, such as "shall," "must," and "require," when it refers to statutory or regulatory requirements. The FDA uses non-mandatory language, such as "should," "may," "can," and "recommend," when it refers to guidance. Each facility needs to follow the final regulations.
Under its own authority, a State may impose more requirements than those specified under MQSA and its implementing regulations. A facility should check with its State and local authorities about their requirements.
This system has several main topics. Topics have subtopics. A subtopic often starts with a citation of the regulation to which it relates. Then, there is a discussion and/or a series of questions and answers offering guidance about how FDA implements the regulation. Some topics end with a list of related topics. To see the contents of a subtopic, click on its title.
If you have comments or questions about the Policy Guidance Help System, please send them via e-mail to MQSAhotline@versatechinc.com.