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Guidance on intervertebral body fusion device

Device Regulation Alert: Safety, Compliance and Reimbursement News, July 9, 2007

In June, the FDA reclassified intervertebral body fusion devices from Class III to Class II, and issued special control guidance for the devices.

The devices are made with titanium and other materials and implanted in the "intervertebral body space of the cervical or lumbrosacral spine," according to the FDA guidance. The reclassification and guidance only apply to such intervertebral body fusion devices with bone grafting material and not intervertebral body fusion devices that include therapeutic biologics such as bone morphogenic protein. Those devices with such therapeutic biologics are still subject to premarket approval as Class III devices.

Manufacturers will save the cost of premarket approval process mandated under Class III designations because of the reclassification, according to notice.

Like similar FDA guidance, the guidance is not "legally enforceable" but gives offers recommendations on how to provide assurance of the safety and effectiveness of these devices.

The guidance suggests what information manufacturers should include with the device. The FDA says to include a description of the device, and descriptions of the instruments used to implant the device. It also suggests that manufacturers identify materials used in the creation of the device itself-including purity, source, and components affected by aging.

To read the guidance, click here.

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