美国FDA指导原则 Class II Special Controls Guidance Document Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff.docxVIP

Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff Document issued on: July 28, 2009 The draft of this document was issued on February 20, 2002. This guidance refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR Part 801 have been approved under OMB control number 09 10-0485, expiration date August 31, 2011. Persons are not required to respond to a collection without a valid OMB number. For questions regarding this document contact Michael E. Adjodha at 301-796-6276 or via email at michael.adjodha@. 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, electronic comments may be submitted to? . When submitting comments, please refer to the exact title of this guidance document. 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 (1192) to identify the guidance you are requesting. Table of Conents INTRODUCTION THE LEAST BURDENSOME APPROACH BACKGROUND SCOPE DESCRIBING YOUR DEVICE IN A 510(K) PREMARKET NOTIFICATION RISKS TO HEALTH COMPOSITION AND PERFORMANCE DATA BIOCOMPATIBILITY LABELING FOR DENTAL PROFESSIONALS Guidance for Industry and FDA StaffClass II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy