Federal Register Proposed rule: FDA is proposing to reclassify intervertebral body fusion devices that contain bone grafting material, from Class 3 (premarket approval) into Class 2 (special controls), and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in Class 3. FDA is also making available a draft guidance document that would serve as the special control if FDA reclassifies this device. The agency is proposing this reclassification based on the recommendation of the Orthopedic and Rehabilitation Devices Panel. To download the guidance, click here. To view this proposed rule, click here.