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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for research and historical reference.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 #9; Guidance for Industry, MQSA Inspectors, and FDA Staff [Text] [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 [Text] [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 [Text] [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 [Text] [PDF]
- The Mammography Quality Standards Act Final Regulations - Modifications
and Additions to Policy Guidance Help System #6; Guidance for Industry and
FDA [Text] [PDF]
- The Mammography Quality Standards Act Final Regulations Modifications and
Additions to Policy Guidance Help System #7; Guidance for Industry and FDA
[Text] [PDF]
- 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Additions to Policy Guidance Help System #6; Draft Guidance for Industry and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 and Action Report 2003 [Text] [PDF]
- Mammography Facility Adverse Event and Action Report 2002 [Text] [PDF]
- Mammography Facility Adverse Event Report 2001 [Text]
- 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
Updated September 2, 2008
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