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PMA for ultrasound breast lesion analysis is consistent with FDA policies -- ATL.

This article was originally published in The Gray Sheet

Executive Summary

PMA REQUIREMENT FOR ULTRASOUND TO DIFFERENTIATE BENIGN AND MALIGNANT breast lesions is supported by FDA policies and guidance documents, attorney Jeffrey Gibbs (Washington, D.C. firm Hyman, Phelps & McNamara) says in comments submitted to FDA on behalf of Advanced Technology Laboratories (ATL). Responding to a citizen's petition from Acuson which argued that differentiation between benign and malignant masses should be a 510(k) claim ("The Gray Sheet" June 12, I&W-4), Gibbs argued that "requiring a PMA...is consistent with long-standing policies. FDA has required PMAs for many devices that make cancer diagnostic claims, including claims relating to breast cancer."
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