Warning Letter Roundup & Recap – May 19, 2015
This article was originally published in The Gray Sheet
Executive Summary
After evaluating information gathered during an FDA inspection and reviewing ZYTO Technologies' website, the agency discovered that the firm promoted its device for functions outside its cleared intended use; MicroAire had no internal systems for determining whether an event was MDR-reportable; and more. Two warning letters were listed by FDA this week.