Ultrasound for differentiating breast lesions should not require PMAs, Acuson tells FDA.
This article was originally published in The Gray Sheet
Executive Summary
ULTRASONIC DIFFERENTIATION OF BENIGN AND MALIGNANT BREAST LESIONS should be reviewed by FDA's radiology and obstetrics/gynecology advisory committees for recommendations on appropriate premarket requirements, Acuson says in a citizen petition filed May 26 with FDA. Concerned that clearance of premarket approval applications for such claims would shut companies without PMAs out of the market, Acuson asks that the panels develop "criteria" for determining which claims require PMAs and which can be cleared via 510(k).
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