(continued) FORM FDA 3500A (10/15) (continued) MEDWATCH Page 3 of 3 B a c k t o I t e m B . 5 B a c k t o I t e m B . 6 B a c k t o I t e m B . 7 B a c k t o I t e m C . 2 B a c k t o I t e m D . 1 1 Reset Form...
·Form FDA 3500A (PDF - 903KB): Medwatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory,"MedWatch安全信息和不良反应报告计划-强制报告"。该表格用于强制性地报告医疗产品相关的不良事件、产品问题和质量问题。要求特定的报告人,如医疗机构和制造商,根据法律或监管要求向FDA提供报...
FDA3500A 表格 Form Approved:OMB No. 0910-0291 Expires: 11/30/00 Page ___ of ___For use by user-facilities,distributors and manufacturers for MANDATORY reporting
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Complete and submit a postage-paid FDA Form 3500and returning by mail/fax Call 1-800-FDA-1088 to request a reporting form In addition, please provide a copy of all FDA MedWatch forms to: http://www.pfizersafetyreporting.com/ or by fax (1-866-635-8337) or phone (1-8...
如果是用FDA3500 10、Form ,在H-2项上注明补充报告;a)在提交的补充报告上要注明正确的识别码;比如制造商报告的编号。b)仅需在各原始报告对应的 FDA3500A相应的章节上填写新的、有变化的或有修正的内容。6.10 MDR事件档案6.10.1 市场部建立和维护 MDR事件档案,所有的 MDR事件档案单独保存,须与一般的投诉文件...