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Medical Device Compliance Post Market Regulation & Studies

FDA Warning Letters

This article was originally published in The Silver Sheet

Executive Summary

Hospira cited for QS reg violations; Dexcom failed to report MDRs to the agency in a timely fashion. Four warning letters listed by FDA from March 18 through April 17.

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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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