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FDA reclassifies blood separator and issues special controls

Device Regulation Alert: Safety, Compliance and Reimbursement News, December 10, 2007

The FDA has reclassified automated blood cell separator device operating on a centrifugal separation principle to Class II. The classification applies when the device is used for routine collection of blood and blood components.

The device operates by drawing blood from a donor, separating the whole blood into blood components, collecting one component and sending the remaining blood and blood components back to the donor. The components removed are used for transfusion or further manufacture.

All other uses of the device (e.g. therapeutic apheresis) remain classified in Class III.

In connection with this reclassification, the FDA also issued special control guidance intended to address adverse events that aren't required to be reported under the Medical Device Reporting regulation. The guidance can also be applied to the automated blood cell separator devices operating on a filtration separation principle.

After the December 31, 2007 effective date of the reclassification rule, device manufacturers submitting premarket notification (510k) for such a device must follow the guidance or otherwise demonstrate the device's safety and effectiveness.

The guidance identifies the risks of the device including blood loss, toxic reaction to anticoagulant used, damage to red blood cells, infection, and embolism.

The guidance instructs manufacturers of currently marketed products that don't have premarket approval to file an annual report for three years on the date of the reclassification to Class II or the date of the premarket notification (510k) clearance. The following information should be included in the annual report:

• Information about adverse events that were not required to be reported.
• Description of any change to the device that requires premarket notification
• Description of change to a class III device on the market before 1976 amendments to the classifications, that requires 30-day notice under 21 CFR 814.39(f).

The guidance notes the FDA hopes to find clusters of adverse events that could indicate a safety issue with the device that wouldn't be uncovered otherwise because the events weren't reported under MDR.

Click here to access the guidance. Click here to read the final rule reclassifying the device in the November 30 Federal Register.

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