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ReGen Declines "Futile" 510(k) Rescission Hearing But Plans Legal Challenge

This article was originally published in The Gray Sheet

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Executive Summary

ReGen Biologics says it is considering several last-ditch options to keep its collagen meniscus scaffold device on the U.S. market, but they do not include another hearing with FDA.

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U.S. District Court rules in FDA’s favor on 510(k) clearance rescission. Gastroenterology & Urology Devices panel to meet in June. 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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