FDA PROPOSES RECLASSIFYING ORTHOPEDIC DEVICE
The FDA wants to reclassify intervertebral body fusion devices that contain bone-grafting materials to a less stringent regulatory category.
According to a new proposed rule and draft guidance, the devices would shift to a class II certification, which requires special and general controls to assure safety and effectiveness. The devices currently are classified under class III -- the agency's most stringent regulatory category, reserved for products for which insufficient information exists to assure safety and effectiveness solely through general or special controls.
"FDA believes the intervertebral body fusion device that contains bone grafting material should be reclassified into class II because special controls, in addition to general controls, can provide reasonable assurance of the safety and effectiveness of the device," the proposed rule states.
There is sufficient information to establish special controls to provide such assurance, the agency added. However, the devices that contain any therapeutic biologic would retain the class III designation, the FDA said.
The FDA's class II special controls guidance for the devices incorporates voluntary consensus standards and labeling recommendations. It also includes sections on material characterization, mechanical testing, animal testing, clinical testing, sterility, biocompatibility and labeling.
The agency's proposal follows the unanimous recommendations of a December 2003 FDA advisory panel committee, which said the devices, except those that contain any therapeutic biologic, should be reclassified from class III into class II.
The proposed rule, "Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device," is at http://www.fda.gov/OHRMS/DOCKETS/98fr/2006n-0019-npr0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2006n-0019-npr0001.pdf). The draft guidance, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device," is at http://www.fda.gov/OHRMS/DOCKETS/98fr/2006d-0020-nad0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2006d-0020-nad0001.pdf). Comments are due May 10.