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Reclassification of Intervertebral Body Fusion Device and Availability of Draft Class II Special Controls Guidance Document for the device

The FDA has announced the reclassification of the Intervertebral Body Fusion Device from a Class III device to a Class II device. Intervertebral Body Fusion Devices that include any therapeutic biologic will continue to be Class III. The agency is proposing this reclassification based on the recommendation of the Orthopaedic and Rehabilitation Devices Panel (the Panel).

FDA believes that the intervertebral body fusion device that contains bone grafting material should be reclassified into class II because special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. In addition, there is sufficient information to establish special controls to provide such assurance.

FDA is accepting written or electronic comments by May 10, 2006.

For more information on this update, please refer to the following links:
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-1736.pdf and
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-1735.pdf

If you have any comments regarding this update, please email: info@mdiconsultants.com

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