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 fre 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。