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Medical Device Regulation

Regulatory News In Brief

This article was originally published in The Gray Sheet

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Executive Summary

FDA issues draft guidance on classification product codes. Black box warning required for ovarian adnexal mass test systems. More regulatory news.

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Regulatory News In Brief

FDA issues guidance on product classification codes and molecular diagnostic instruments with combined functions. More regulatory news.

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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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