也可以使用其他与相应审查部门的监管项目经理进行快速沟通的方式(例如,电话、传真、电子邮件)。 二、Postmarketing Adverse Event reporting requirements Postmarketing Adverse Event Reporting Compliance Program | FDA 1.如何报告不良事件 消费者、护理人员和医疗保健专业人员:使用MedWatch(消费者填写 FDA3500B 表格、医...
FDA Adverse Event Reporting System (FAERS) is a useful tool for FDA to monitor various activities. FDA Adverse event reporting requirements include: Looking out for new safety concerns that might be related to a marketed product Evaluating a manufacturer’s compliance to reporting regulations ...
Adverse Event Reporting:Companies must report any adverse events or serious side effects associated with the use of hydrogen peroxide to the FDA. Packaging Requirements:Hydrogen peroxide products must be packaged in a manner that protects the product from contamination and protects users from injury. T...
报告不良事件（Adverse Event Reporting）：制造商需要及时向FDA报告与其医疗器械相关的不良事件和意外，以便FDA能够监测潜在的风险。临床试验：某些高风险设备可能需要进行临床试验，以提供充分的安全性和有效性数据。注册与上市通知（Registration and Listing）：制造商需要在FDA注册其设施，并向FDA提交设备清单，确保FDA能...
Sec. 803.19 Are there exemptions, variances, or alternative forms of adverse event reportingrequirements? (a) We exempt the following persons from the adverse event reporting requirements in this part:差异有豁免,或其他形式的不良事件报告的要求? (1) A licensed practitioner who prescribes or administer...
FDA Adverse Event Reporting System (FAERS) Quarterly Data Files FDA不良事件报告系统(FAERS)季度数据文件Downloadable data files. 可下载的数据文件 FDA Adverse Event Reporting System (FAERS) Public Dashboard FDA不良事件报告系统(FAERS)公告板 Inactive Ingredient Search for Approved Drug Products Search获批药...
FDA Adverse Event Reporting System (FAERS) Quarterly Data Files FDA不良事件报告系统(FAERS)季度数据文件Downloadable data files. 可下载的数据文件 FDA Adverse Event Reporting System (FAERS) Public Dashboard FDA不良事件报告系统(FAERS)公告板 Inactive Ingredient Search for Approv...
Therefore, adverse event reports from investigators are critically important. To help investigators identify unanticipated safety information during clinical investigation and comply with safety reporting requirements, FDA issued the Investigator Responsibilities — Safety Reporting for Investigational Drugs and ...
Subpart B - Generally Applicable Requirements for Individual Adverse Event Reports( § 803.20- § 803.23) Subpart C - User Facility Reporting Requirements( § 803.30- § 803.33) Subpart D - Importer Reporting Requirements( § 803.40- § 803.42) ...
Labeling and Packaging Requirements: FDA规定了医疗器械标签和包装的要求,以确保患者和医疗专业人员能够正确使用和理解产品。Adverse Event Reporting: 制造商需要报告任何与其产品相关的不良事件,包括患者伤害、产品缺陷等。Unique Device Identification (UDI): FDA要求医疗器械制造商分配和报告唯一设备标识(UDI),以提高对...