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Information
for mammography facility personnel, inspectors, and consumers
about the implementation of the Mammography Quality Standards Act of 1992
(MQSA) |
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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for research and historical reference.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Additions to Policy Guidance Help System #6; Draft Guidance for Industry and
FDA [Text] [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) [Text] [PDF]
- Policy and Standard Operating Procedures When Mammography Facilities in
States that have Accreditation Bodies Intend to Change Accreditation Bodies
(issued 4/15/98)[Text] [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) [Text]
[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) [Text]
[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) [Text] [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)
[Text] [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) [Text] [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)
[Text] [PDF]
- The Mammography Quality Standards Act Final Regulations Document #4; Final
Guidance for Industry and FDA
(posted 5/24/2001) [Text]
[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)
[Text] [PDF]
Mammography Facility Adverse Event and Action Reports (formerly Mammography
Facility Adverse Event Reports) These annual reports are mandated by MQSA, Sec.
354(1):
- Mammography Facility Adverse Event Report 2000 [Text] [PDF]
- Mammography Facility Performance Report: Calendar Year 1999 [Text] [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
Other Documents
- MQSA Program Accomplishments, June 1993 through September 2003 [Text]
- 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]
Updated September 3, 2004
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