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  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Cord Blood Processing System and Storage Container - Class II Special Controls Guidance for Industry

Read the Special Controls Document

Issue Date: 03/01/2011

Issued By: Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research

This document was developed as a special control to support the classification of a cord blood processing system and storage container into class II (special controls). This guidance is relevant to devices intended for use in the processing and the storage of cord blood.