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Mammography
Description
Procedures
(entry to be developed)
Risks/Benefits
- Reports of interest to industry and other members
of the public on implementation of the MQSA, e.g., demonstration projects and reports to Congress
Laws, Regulations & Standards
- The law, the MQSA, as amended in 1998 and 2004 Updated May 26, 2005
- Regulations
implementing the MQSA (Title 21, Code of Fedearl Regulations, Part 900, MAMMOGRAPHY) Updated May 31, 2002
- Public Notices
published in the Federal Register relating to the MQSA
- Alternative Requirements
for complying with various sections of 21 CFR Part 900 Updated June 29, 2005
Advice to Professionals
(entry to be developed)
Industry Guidance
-
Ensuring high quality mammography services due to the effects of natural disaters on
mammographic facilities Updated September 22, 2005
- FDA assistance,
for individuals affected by hurricane Katrina, in qualifying personnel for mammography -
documenting adequacy of qualfications under the MQSA Updated September 22, 2005
- Policy Guidance Help System
(PGHS), organized by topic
Information
for users of the original PGHS "Search" function
-
Guidance for complying with the MQSA
- Guidance
for Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical
Physicist Qualification Requirements under MQSA Updated October 4, 2005
- Draft guidance PDF for
Industry and FDA staff (issued for comment, July 15, 2005)
-
Certification and Inspection of facilities Updated Septembr 16, 2005
- FDA Approval
of accreditation of Siemens Mammomat Novation DR Full-Field Digital Mammography
Units by the American College of Radiology October 7, 2005
- Requirements
for initial training and continuing medical education remain in effect during use of
additions to Policy Guidance Help System #11
- Other Guidance Documents
Other Resources
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