A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) re is significantly changed or modified in design, components, method of manufacture, or intended use. Significant changes or modifications are those that could significantly affect the safety or effectiveness of the device, or major changes or modifications in the intended use of the device。

As to the detail is following

Labeling changes

Technology, engineering, and performance changes

Materials changes

Technology, engineering, performance, and materials changes

Considerations for risk-based assessments of modified devices

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

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

Addition of a new patient population

Changes  the environment of use such as from professional use to home use or hospital use to ambulatory transport

Changes  in frequency or duration of use

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

Changes  in sterilization, cleaning or disinfection

Changes in package integrity or shelf-life claims

Changes  in device design

Changes  to employ wireless communication

Changes in the human factors of the patient or user interface

A  change in material type, formulation or chemical composition

Changes in the antibody, detection reagents, critical reaction components or conjugates for in vitro diagnostic (IVD) devices

深圳市思博达医疗技术服务有限公司（Shenzhen Bosstar Consult Company Limited, 简称BCC）是一家从事医疗器械国际咨询的专业性咨询机构。提供各个国家或地区医疗器械注册认证，包括中国NMPA、美国FDA、510(K)、欧盟MDR CE认证、加拿大MDL认证、澳洲TGA认证等等、医疗器械质量体系审查，如中国医疗器械GMP（包括试剂类）、美国QSR820质量体系场考核、欧盟GMP、日本GMP、巴西GMP、ISO13485等）等多种国际注册及认证的咨询、代理服务；也可为您提供医疗器械风险管理、软件确认、灭菌确认、临床评估、可用性确认等专题培训服务。