美国FDA指导原则 Class II Special Controls Guidance Document Surgical Sutures.docxVIP

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Surgical Sutures Document issued on: June 3, 2003 This document supersedes Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA dated December 19, 2002 For questions regarding this document, contact David Krause at 301-796-6970 or by email at david.krause@. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health Plastic and Reconstructive Surgery Devices BranchDivision of General, Restorative, and Neurological DevicesOffice 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 with respect to absorbable polydioxanone surgical suture (21 CFR 878.4840), please refer to the exact title of this guidance document. When submitting comments with respect to sutures?other thanthe absorbable polydioxanone surgical suture, please refer to Docket No. 02D-0289. 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 1387 to identify the guidance you are requesting. TABLE OF CONTENTS 1. INTRODUCTION 2. BACKGROUND 3. THE CONTENT AND FORMAT OF AN ABBREVIATED 510(K) SUBMISSION 4. SCOPE 5. DEVICE DESCRIPTION 6. RISKS TO HEALTH 7. BIOCOMPATIBILITY 8. STERILITY 9. PHYSICAL/PERFORMANCE CHARACTERISTICS 10. CLINICAL STUDIES 11. LABELING Guidance for Industry and FDA StaffClass II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry