FDA follows its Good Guidance Practice’s protocol when issuing guidance. Guidance is developed in response to questions we receive from the mammography community, patients and other interested parties. FDA issues guidance as either draft or final. Draft guidance is issued when the matter being addressed is new, complicated or controversial. Draft guidance is published for public comment and is issued as final only after the public’s comments are considered. Guidance is issued as final if it not new, complicated or controversial or has already gone through the draft process.
Drafts of proposed guidance currently open for public comment will be provided in the section below. Final guidance documents may be accessed by clicking on Final Guidance. Final Guidance is also incorporated into the Policy Guidance Help System. Guidance in the Policy Guidance Help System represents FDA's current thinking on the MQSA final regulations.
Other Guidance Documents
Documents that provide additional assistance in complying with MQSA requirements include:
Mammography Equipment Evaluation (MEE) Scope for Newly Installed FFDM Systems[ARCHIVED] Notification Protocols When a Facility Moves a Mammography Unit Laser Printer Test Procedures in the Current FFDM Manufacturer QC Manuals Communicating Mammography Results to Women(PDF - 1.7MB) Industry Guidance