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FDA MAMMOGRAPHY QUALITY STANDARDS INTERIM REG

This article was originally published in The Gray Sheet

Executive Summary

FDA MAMMOGRAPHY QUALITY STANDARDS INTERIM REG seeks advice on standards that should be established for mammography of patients with breast implants. Published in the Dec. 21 Federal Register, the interim final reg explains that "FDA does not believe that sufficient information is presently available with regard to special requirements for mammography of patients with breast implants." The agency asks for "comments on standards for consideration in development of the final rule."

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