美国FDA 指导原则 行业和CDRH审查员指南1-一个设备产品线的综合年度报告(单卡)试点编制心脏起搏器上市前批准申请的年度报告 英文原版.pdfVIP

Guidance for Industry and CDRH Reviewers 1-Consolidated Annual Report for a Device product line (1-CARD) Pilot for preparation of annual reports for pacemaker premarket approval applications1 Document issued on: July 6, 2000 U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Pacing and Electrophysiology Devices Group Division of Cardiovascular and Respiratory Devices Office of Device Evaluation 2 Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Mitchell Shein, Director, Division of Cardiovascular and Respiratory Devices, Office of Device Evaluation, HFZ-450, 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 Mitchell Shein at (240) 276-4080 or email Mitchel.Shein@. Additional Copies Additional copies are available at the World Wide Web/ CDRH/ home page: /cdrh/ode/guidance/1167.pdf or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 1167 when prompted for the document shelf number. 3 1-Consolidated Annual Report for a Device product line (1-CARD)1 Pilot for preparation of annua