Zdrowie i gospodarka · 1.02.2007
Guidance for Industry; Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container." The guidance document describes a means by which a cord blood processing system and storage container may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying a cord blood processing system and storage container into class II (special controls). This guidance document is immediately in effect as the special control for this device, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).