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Promoting Your 510(k)-Pending Device: 5 Questions About FDA's Policy

Executive Summary

A 510(k) submission rather than a 510(k) clearance is the threshold that a device firm needs to meet to begin advertising or displaying a product under a long-established, one-sentence agency policy. But important questions remain about proper application of this policy by industry, Hyman, Phelps & McNamara attorney Jeffrey Shapiro writes in this guest column.

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