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Medical Device Regulation Compliance

Warning Letter Roundup & Recap –December 22, 2015

This article was originally published in The Gray Sheet

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Executive Summary

Device firm Elite Massagers received two complaints – including one that described a user being shocked by an Elite Multi device – yet failed to investigate; Dutch Ophthalmic Research Center cited for premarket violations. Two device warning letters were listed by FDA last week.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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