MQSA Final Guidance

Documents that provide approved guidance in complying with MQSA requirements include:

Note: Final Guidance documents are incorporated into the Policy Guidance Help System (PGHS)

• Guidance for Industry, MQSA Inspectors and FDA Staff - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13
• Guidance for Industry, MQSA Inspectors, and FDA - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #12 [This document has been archived]
• The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9; Guidance for Industry, MQSA Inspectors, and FDA Staff [This document has been archived]
• The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #10; Guidance for Industry, MQSA Inspectors, and FDA Staff [This document has been archived]
•  The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #11; Guidance for Industry, MQSA Inspectors, and FDA Staff [This document has been archived]
• The Mammography Quality Standards Act Final Regulations - Modifications and Additions to Policy Guidance Help System #8; Guidance for Industry and FDA [This document has been archived]
• The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA [This document has been archived]
• The Mammography Quality Standards Act Final Regulations - Modifications and Additions to Policy Guidance Help System #6; Guidance for Industry and FDA [This document has been archived]
• The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #5 - Guidance for Industry and FDA [This document has been archived]
• MQSA Final Regulations: Modifications and Additions to Policy Guidance Help System #4; Guidance for Industry and FDA [This document has been archived]
• MQSA Final Regulations Modifications and Additions to Policy Guidance Help System #3; Final Guidance for Industry and FDA [This document has been archived]
• MQSA Final Regulations: Modifications to the Policy Guidance Help System Due to the September 11, 2001 Terrorist Attacks; Final Guidance for Industry and FDA [This document has been archived]
• The Mammography Quality Standards Act Final Regulations Document #4; Final Guidance for Industry and FDA [This document has been archived]
• MQSA Final Regulation Modifications and Additions to Policy Guidance Help System #2; Final Guidance for Industry and FDA (issued 1/24/01, posted 2/12/01) [This document has been archived]

Inspections/Surveys Guidance

• Compliance Guidance: Preparing for MQSA Inspections (updated 11/5/01; posted 11/29/01) [PDF]
• Guidance for Industry and FDA Staff - Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under MQSA (updated 10/4/05, posted 11/8/00)

Accreditation/Certification Guidance

• Guidance for Request And Issuance Of Interim Notice Letters For Mammography Facilities Under The Mammography Quality Standards Act, 42 U.S.C. § 263(b) [This document has been archived]
• Policy and Standard Operating Procedures When Mammography Facilities in States that have Accreditation Bodies Intend to Change Accreditation Bodies [This document has been archived]
• Guidance for Review of Requests for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. § 263(b) [This document has been archived]
• Guidance for Submission of Requests for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C § 263(b) [This document has been archived]

Other Guidance

• Compliance Guidance: The Mammography Quality Standards Act Final Regulations; Quality Assurance Documentation (issued 12/7/99) [This document has been incorporated into the Policy Guidance Help System]
• Compliance Guidance: The Mammography Quality Standards Act Final Regulations Motion of Tube-Image Receptor Assembly (issued 3/23/99) [This document has been incorporated into the Policy Guidance Help System]