FDAnews Device Daily Bulletin

FDA ISSUES FINAL GUIDANCE OF MAMMOGRAPHY STANDARDS

April 19, 2006
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The FDA has issued its final guidance regarding mammography standards, "Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9." The guidance will be published in the Federal Register.

The draft guidance was first issued on July 15, 2005. Modifications in the final guidance include clarifying small field digital mammography requirements and the uses of digitized or compressed mammographic images, as well as ensuring that full field digital mammography images used for final interpretation contain certain identifying information. The document also makes recommendations regarding the use of foreign-trained physicians and quality control testing standards when using cushion pads on compression devices.

To view the guidance, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0195-gdl0002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0195-gdl0002.pdf).