Federal Register Proposed rule: FDA is proposing to reclassify tricalcium phosphate granules for dental bone repair from Class III to Class II (special controls); classify into Class II (special controls) all other bone grafting material for dental indications, except those that contain drug or biologic components; and revise the classification name and identification of the device. A special controls guidance document is being made available. Bone grafting materials that contain a drug or biologic component would remain in Class III. The proposed classification identification includes materials such as hydroxyapatite, demineralized bone additives, collagen, and polylactic acids. To view this proposed rule, click here. To download the guidance document, click here.
