美国FDA指导原则 Class II Special Controls Guidance Document Dental Bone Grafting Material Devices.docxVIP

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices Document issued on: April 28, 2005 The draft of this document was issued on June 30, 2004. For questions regarding this document, contact Bob Betz at 301-796-6277 or via email at robert.betz@. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health Dental Devices BranchDivision of Anesthesiology, Infection Control,General Hospital, and Dental DevicesOffice of Device Evaluation Preface Public Comment Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, e lectronic comments may be submitted to? R. When submitting comments, please refer to Docket No. 2004D-0178. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet. You may also send an e-mail request to? CDRH-Guidance@?to receive a copy of the guidance. Please use the document number 1512 to identify the guidance you are requsting. Table of Contents Introduction Background The Content and Format of an Abbreviated 510(k) Submission Scope Device Description Risks to Health Material Characterization Biocompatibility Sterilization Labeling Guidance for Industry and FDA StaffClass II Special Controls Guidance Document: Dental Bone Grafting Material Devices 1. Introduction This guidance document was developed as a special controls guidance to support the classification and reclassification of certain dental bone grafting material devices into class II. The device is a material that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. FDA is issuing this guidance in conjunction wi