FDA ISSUES FINAL RULE, GUIDANCE ON CLASSIFICATION OF CORD BLOOD CONTAINERS

The FDA has published a final rule and guidance classifying a cord blood processing system and storage container into Class II (special controls).

The device is a functionally closed processing system that includes containers, other soft goods and a centrifugation system for cord blood concentration, as well as a final container for the cryopreservation and storage of a cord blood product.

The final rule can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/cb0637.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/cb0637.pdf).

The guidance, ''Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container,'' can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/07d-0025-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0025-gdl0001.pdf).