美国FDA 指导原则 为业界和CDRH工作人员提供的第II类设备豁免上市前通知指南的程序(PDF格式) 英文原版.pdfVIP

Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff This document is intended to provide guidance. It represents the Agency’s current thinking on the above. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. Premarket Notification (510(k)) Staff, Program Operations Staff (POS), Office of Device Evaluation Document issued on: February 19, 1998 Until May 26, 1998, comments and suggestions regarding this document should be submitted to Docket No. 98D-0083, Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 12420 Parklawn Drive (HFA-305), Room 1-23, Rockville, MD 20857. Such comments will be considered when determining whether to amend the current guidance. After May 26, 1998, comments and suggestions may be submitted at any time for Agency consideration to, Heather Rosecrans, Chief, Premarket Notification Staff, HFZ-404, 9200 Corporate Blvd., Rockville, MD 20850. 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 Heather Rosecrans at 301-594-1190. Additional Copies: World Wide Web/CDRH home page at /cdrh or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 159 when prompted for the document shelf number. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Center for Devices and Radiological Health (CDRH)