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