Medical devices; hematology and pathology devices; classification of cord blood processing system and storage container. Final rule.
The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container." FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
D002469:Cell Separation / Q000145:classification* / Q000295:instrumentation; D015925:Cryopreservation / Q000145:classification* / Q000295:instrumentation; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety; D005312:Fetal Blood; D006405:Hematology / Q000295:instrumentation / Q000331:legislation & jurisprudence; D006801:Humans; D010336:Pathology / Q000295:instrumentation / Q000331:legislation & jurisprudence; D013048:Specimen Handling / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration