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Device Warning Letters FDA Enforcement

Warning Letter Roundup & Recap – April 9, 2019

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Executive Summary

In the only device-related warning letter released by the US FDA this week, Inova Genomics Laboratory was dinged for selling products without premarket approval.

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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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