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Medical Device

Menaflex: The Winding Road To Rescission

This article was originally published in The Gray Sheet

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Executive Summary

FDA announced on Oct. 14 that it plans to seek rescission of ReGen Biologics' 510(k) for the Menaflex collagen scaffold. The device has already experienced many twists and turns along the regulatory pathway, as this timeline suggests:

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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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