Radiation-Emitting Products
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Document Archives (MQSA)
Archived Documents - Not for Official Use
Although some of the information in these documents has been modified or no longer applies to MQSA regulatory requirements, these items are presented here for research and historical reference.
Previously Issued Guidance
- The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #12; Guidance for Industry, MQSA Inspectors, and FDA Staff [Text and PDF]
- The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9; Guidance for Industry, MQSA Inspectors, and FDA Staff [Text and PDF]
- The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #10; Guidance for Industry, MQSA Inspectors, and FDA Staff [PDF]
- The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #11; Guidance for Industry, MQSA Inspectors, and FDA Staff [PDF]
- NOTE: Since issuing Guidance Document #11, which deals with indefinitely delaying the enforcement of the requirement for CONTINUING education in each MAMMOGRAPHIC MODALITY used, we have received a number of inquiries asking whether there has been any change in the requirement for eight hours of INITIAL training in each new mammographic modality. Please be aware that there has been no change in the requirement for eight hours of INITIAL training in each new mammographic modality prior to independent use and this INITIAL requirement continues to be enforced. There also has been no change in our enforcement of the basic 15 hours of continuing medical education every 36 months.
- The Mammography Quality Standards Act Final Regulations - Modifications and Additions to Policy Guidance Help System #8; Guidance for Industry and FDA [PDF]
- The Mammography Quality Standards Act Final Regulations - Modifications and Additions to Policy Guidance Help System #6; Guidance for Industry and FDA [PDF]
- The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA [PDF]
- The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6; Draft Guidance for Industry and FDA [PDF]
- Guidance for Request And Issuance Of Interim Notice Letters For Mammography Facilities Under The Mammography Quality Standards Act, 42 U.S.C. § 263(b) (Updated 5/27/99) [PDF]
- Policy and Standard Operating Procedures When Mammography Facilities in States that have Accreditation Bodies Intend to Change Accreditation Bodies (issued 4/15/98) [PDF]
- 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) (issued 3/26/98) [PDF]
- 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) (issued 3/26/98) [PDF]
- The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #5 - Guidance for Industry and FDA (issued 7/8/2002) [PDF]
- MQSA Final Regulations: Modifications and Additions to Policy Guidance Help System #4; Guidance for Industry and FDA (issued 3/25/02, posted 4/2/02) [PDF]
- MQSA Final Regulations Modifications and Additions to Policy Guidance Help System #3; Final Guidance for Industry and FDA (issued 11/5/01; posted 11/29/2001) [PDF]
- MQSA Final Regulations: Modifications to the Policy Guidance Help System Due to the September 11, 2001 Terrorist Attacks; Final Guidance for Industry and FDA (issued 10/5/01, posted 10/15/01) [PDF]
- The Mammography Quality Standards Act Final Regulations Document #4; Final Guidance for Industry and FDA (posted 5/24/2001) [PDF]
- 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) [PDF]
Mammography Facility Adverse Event and Action Reports (formerly Mammography Facility Adverse Event Reports)
These annual reports are mandated by MQSA, Sec. 354(1):
NOTE: In order to provide this information to the public in a more timely manner, we have published the first semi-annual report.
Semi-Annual Report:
- Mammography Facility Adverse Event and Action Report - December 9, 2010
- Mammography Facility Adverse Event and Action Report - January through June 2010
- Mammography Facility Adverse Event and Action Report - July through December 2009
- Mammography Facility Adverse Event and Action Report - January through June 2009
Annual Reports:
- Mammography Facility Adverse Event and Action Report 2008
- Mammography Facility Adverse Event and Action Report 2007
- Mammography Facility Adverse Event and Action Report 2006
- Mammography Facility Adverse Event and Action Report 2005
- Mammography Facility Adverse Event and Action Report 2004
- Mammography Facility Adverse Event and Action Report 2003 [PDF]
- Mammography Facility Adverse Event and Action Report 2002 [PDF]
- Mammography Facility Adverse Event Report 2001 [Text]
- Mammography Facility Adverse Event Report 2000 [PDF]
- Mammography Facility Performance Report: Calendar Year 1999 [PDF]
- Mammography Facility Performance Report: Calendar Year 1998 (amended -- June 2000) [PDF]
- Mammography Facility Performance Report: Calendar Year 1997 [PDF]
- Mammography Facility Performance Report: Calendar Year 1996 [PDF]
- Mammography Facility Performance Report: Calendar Year 1995 [PDF]
Mammography Matters Newsletter
- Winter 2000 [PDF]
- Spring 2000 [PDF]
- Winter 1999 [PDF]
- Fall 1999 [PDF]
- Summer 1999 [PDF]
- Spring 1999 [PDF]
- Winter 1998 [PDF]
- Fall 1998 [PDF]
- Summer 1998 [PDF]
- Spring 1998 [PDF]
Other Documents
- MQSA Inspection Procedures 6.05 – (9/22/09) [PDF]
- Digital Mammography Use Reaches the 50% Milestone
- Facility Personnel Affected by Hurricane Katrina
- Mammography Facility Satisfaction Survey
- Inspection Demonstration Project (IDP): The Effect of Reducing Inspection Frequency [PDF]
- 2000 Report to Congress
- Full Report [PDF]
- Executive Summary [PDF]
- 2001 Report to Congress
- Full Report [Text]
- Executive Summary [Text]
- 2002 Report to Congress
- Full Report [Text]
- Executive Summary [Text]
- 2003 Report to Congress
- Full Report [Text]
- Executive Summary [Text]
- 2004 Report to Congress
- Full Report [Text]
- Executive Summary [Text]
- 2005 Report to Congress
- Full Report [PDF]
- Executive Summary [PDF]
- 2006 Report to Congress
- Full Report [PDF]
- Executive Summary [PDF]
- 2007 Report to Congress
- Full Report [PDF]
- 2008 Report to Congress
- Full Report [PDF]
- 2009 Report to Congress
- Full Report [PDF]
- MQSA Program Accomplishments, June 1993 through September 2003 [PDF]
- October 28, 2002 is Fast Approaching... Are you ready? [Text]
- MQSA Quick Tips II - Interim Notice (5/99) [PDF]
- Speaker Kits (4/99) [Text]
- State of Ohio Letter Regarding State Medical Physicist Certificate Program (8/01) [Text]
- Questions and Answers on Medical Physicist Review of Initial Requirements - October 26, 1999, Letter to Medical Physicists (10/99) [Text]
- Presentation: Final Mammography Quality Standards Act (MQSA) Regulations (4/99) [PDF]
- Information on the February 18, 1999 Teleconference [Text]
- Scorecard Statistics [Text]
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