Home » FDA ISSUES UPDATED GUIDANCE ON MAMMOGRAPHY STANDARDS
FDA ISSUES UPDATED GUIDANCE ON MAMMOGRAPHY STANDARDS
The FDA has issued an update of previous guidance on mammography quality standards.
The guidance deals with:
Reducing the annual facility reporting requirements to accreditation bodies;
Quality control testing of infrequently used laser printers used for full field digital mammography; and
Clarifying the information that needs to be supplied to the certificate extension program for computed radiography digital mammography systems.
The "Guidance for Industry, MQSA Inspectors, and FDA Staff -- The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #12," can be viewed at www.fda.gov/CDRH/MAMMOGRAPHY/pubs/1623.pdf (http://www.fda.gov/CDRH/MAMMOGRAPHY/pubs/1623.pdf).
KEYWORDS FDAnews Device Daily Bulletin
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