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).