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In Brief: "Simplified" warning letters

This article was originally published in The Gray Sheet

Executive Summary

"Simplified" warning letters: Center for Devices and Radiological Health's Office of Compliance finalizes "user-friendly" warning letter format with simplified language for first-time offenders and individuals not familiar with FDA. The letter is designed for new, smaller businesses that are marketing and/or selling a device without 510(k) clearance...
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