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FDA Inks Class II Designation For Embryo Viability Tests

This article was originally published in The Gray Sheet

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Executive Summary

The agency set a class II with special controls designation for assisted reproduction embryo image assessment systems in a Feb. 26 final order, following the de novo decision for Auxogyn’s Eeva system last summer.

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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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