Open Public Meeting - Human Bone Allograft August 2, 2000 - Slide Presentation Overview of the History of FDA Regulation of Devices Made From Bone Aric Kaiser, MS Orthopaedic Devices Branch Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Definition of Device May 28, 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act Definition of Device "...apparatus,., implant, ..., including any component.or accessory...intended for the diagnosis, mitigation, treatment, or prevention of disease...or intended to affect the structure or function of the body...and does not achieve its primary intended purposes through chemical action within or on the body.and which is not dependent upon being metabolized."         FD&C Act 201(h) CDRH Review of Bone Products Dental Devices Branch Orthopaedic Devices Branch Restorative Devices Branch CDRH Review of Bone Products dental uses of bone products freeze-dried bone in various shapes and sizes and freeze-dried demineralized bone fill defects reconstruction CDRH Review of Bone Products Dental Devices Branch bone graft substitutes/bone void fillers preamendments unclassified with recommendation of II or III (indication-dependent) CDRH Review of Bone Products Dental Devices Branch Biocoll Laboratories TBM Sponge freeze-dried bone in collagen sponge used to fill periodontal defects CDRH Review of Bone Products ortho/neuro uses of bone products freeze-dried/fresh-frozen bone in various shapes and sizes and freeze-dried demineralized bone fill defects reconstruction CDRH Review of Bone Products Orthopaedic/Restorative Devices Branches bone graft substitutes/bone void fillers many postamendments class III, e.g., Norian SRS, Interpore ProOsteon 500 calcium sulfate preamendments CDRH Review of Bone Products Orthopaedic/Restorative Devices Branches devices manufactured from shaped bone similar to "traditional" devices manufactured from metals, polymers, etc. for same intended use evaluation of spectrum of bone products one end - bone as tissue other end - bone as device middle - bone as ? CDRH Review of Bone Products Orthopaedic/Restorative Devices Branches Bonutti Research Multitak SS allograft cortical bone soft tissue anchor equivalent to metal and polymer versions of same device

Updated April 9, 2001

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