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  1. Guidance (MQSA)

Policy Guidance Help System

The Policy Guidance Help System was last updated October 11, 2017.

New Format for the PGHS

Due to changes in the Food and Drug Administration web system, MQSA Program has reformatted the Policy Guidance Help System (PGHS). Since its inception in the 1990's, the PGHS has been the repository of all guidance issued by the Division of Mammography Quality Standards, consolidated in one place for easy reference by the entire mammography community and consumers.

The new format has advantages for users: it has an index, it's searchable, and it has a glossary. Also, the entire PGHS can be downloaded in an easy-to-use Compiled HTML Help File format; this Help File version is small in size, so it can be easily downloaded over the slowest Internet connection. However, you must have WinZip or equivalent software to decompress the downloaded file.

We have corrected some transcription errors which were pointed out to us by users of the PGHS; however, the policy content is unchanged.


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.



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