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Genzyme gains HDE with conditions

This article was originally published in The Gray Sheet

Executive Summary

Biotherapeutic products firm receives Humanitarian Device Exemption approval for its Epicel cultured epidermal autograft on Oct. 25. Genzyme Biosurgery's skin graft replaces the epidermis of severely burned patients using the person's own healthy skin cells. FDA conditions for device approval include creating a database of Epicel patient information, to be included in a National Xenotransplantation Database, and reporting to FDA subsequent testing results, adverse event information and manufacturing changes. The conditions also include provisions on cell viability data, detecting endotoxins and other quality control requirements. FDA added cultured epidermal autografts to its list of tracked devices in FDA guidance updated Oct. 25
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