ClassIISpecialControlsGuidanceDocument.docVIP

PAGE 17 Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA Document issued on: [Level 2, use Final Rule date ] This document supersedes “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement 510(k)s; Final Guidance for Industry” dated August 2, 2001. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Orthopedic Devices Branch Division of General, Restorative, and Neurological Devices Office of Device Evaluation Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. 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. For questions regarding the use or interpretation of this guidance contact Hany W. Demian at (301) 594-2036, ext.184 or by electronic mail at hwd@. Additional Copies Additional copies are available from the Internet at:  HYPERLINK /cdrh/[specific /cdrh/ode/668.html, or CDRH Facts-On-Demand. In order to receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (668) followed by the pound sign (#). Follow the remaining voice prompts to complete your request. TABLE OF CONTENTS  TOC \o 1-1 1. Introduction  PAGEREF _To\h 4 2. Background  PAGEREF _To\h 4 3. The Content and Format of an Abbreviated 510(k) Submission  PAGEREF _To\h 5 4. Scope  PAGEREF _Toc1278558