什么情况下的变更需要重新提交510(K ), 510（K）在什么情况下需要提交变更

产品详情

Medical devices undergo frequent modifications to their design and materials due to many things; changes in the supply chain, continuous process improvement, or to keep pace with technological innovations that can improve how these devices work in a clinical setting. Major modifications to the device likely require premarket review by the FDA, while minor changes likely do not.

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 of modifications that may require a new 510(k) include, but are not limited to, the following:

可能需要新510(k)的修改示例包括但不限于以下内容:

• A change in indications for use from prescription use to over the counter use

• 从处方用药到非处方用药适应症的改变

• Addition of a new patient population

• 增加新的患者群体

• Changes to the environment of use such as from professional use to home use or hospital 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 frequency or duration of use

• 使用频率或使用持续时间的变化

• Change to indicate compatibility with a type of  device, component, or accessory that was not indicated as compatible with the previously cleared device

• 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 in sterilization, cleaning or disinfection

• 灭菌、清洁或消毒方面的变化

• Changes in package integrity 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 device design

• 器械设计的变化

• Changes to employ wireless communication

• 采用无线通信的变化

• Changes in the human factors of the patient or user  interface

• 患者或用户界面的人为因素的变化

• A change in material type, formulation or chemical composition

• 材料类型、配方或化学成分的变化

• Changes in the antibody, detection reagents,      critical reaction components 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