中山 FDA 510( K ）变更的几种情形

Medical devices undergo frequent modifications to their design andmaterials due to many things; changes in the supply chain,continuous process improvement, or to keep pace with technologicalinnovations that can improve how these devices work in a clinicalsetting. Major modifications to the device likely require premarketreview by the FDA, while minor changes likely donot.

医疗器械由于多方面的原因，其设计和材料需要经常修改;供应链的变化，持续的流程改进，或者跟上技术创新的步伐，这些创新可以改善这些设备在临床环境中的工作方式。对设备的重大修改可能需要FDA的上市前审查，而小的修改可能不需要。

Examples ofmodifications that may require a new 510(k) include, but are notlimited to, the following:

可能需要新510(k)的变更的示例，包括但不限于以下内容:

• A change inindications for use from prescription use to over the counteruse

• 从处方用药到非处方用药适应症的改变

• Addition of a newpatient population

• 增加新的患者群体

• Changes to theenvironment of use such as from professional use to home use orhospital use to ambulatory transport

• 使用环境的变化，例如从专业使用到家庭使用或医院使用或到流动运输

• Changes in frequencyor duration of use

• 使用频率或使用持续时间的变化

• Change to indicatecompatibility with a type of  device, component, or accessorythat was not indicated as compatible with the previously cleareddevice

• 更改为指示与先前清除的设备不兼容的设备、组件或附件类型的兼容性

• Changes insterilization, cleaning or disinfection

• 灭菌、清洁或消毒方面的变化

• Changes in packageintegrity or shelf-life claims

• 包装完整性或货架有效期（保质期）声明的变化

• Changes in devicedesign

• 器械设计的变化

• Changes to employwireless communication

• 采用无线通信的变化

• Changes in the humanfactors of the patient or user  interface

• 患者或用户界面的人为因素的变化

• A change in materialtype, formulation or chemical composition

• 材料类型、配方或化学成分的变化

• Changes in theantibody, detection reagents,      critical reactioncomponents or conjugates for in vitro diagnostic (IVD)     devices

• 体外诊断(IVD)设备的抗体、检测试剂、关键反应组分或偶联物的变化

问：公司已注册的产品需要FDA510（K）变更，联系谁，联系方式是什么？

答：需要进行FDA510（K）的朋友老板，请联系深圳市思博达彭先生，电话微信都行，注明信息来自顺企网有特别优惠，有关美国FDA医疗器械产品注册备案其他问题，随时欢迎沟通和联系。