Apremarket notification (510(k)) is required when a legally marketeddevice subject to 510(k) requirements is significantly changed ormodified in design, components, method of manufacture, or intendeduse. Significant changes or modifications are those that couldsignificantly affect the safety or effectiveness of the device, ormajor changes or modifications in the intended use of thedevice。
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 modifieddevices
Examplesof modifications that may require a new 510(k) include, but are notlimited to, the following:
A change inindications for use from prescription use to over the counteruse
Addition of a newpatient population
Changes theenvironment of use such as from professional use to home use orhospital use to ambulatory transport
Changes infrequency or duration of use
Change to indicatecompatibility with a type of device, component, or accessory thatwas not indicated as compatible with the previously cleareddevice
Changes insterilization, cleaning or disinfection
Changes in packageintegrity or shelf-life claims
Changes indevice design
Changes toemploy wireless communication
Changes in the humanfactors of the patient or user interface
A change inmaterial type, formulation or chemical composition
Changes in theantibody, detection reagents, critical reaction components orconjugates for in vitro diagnostic (IVD) devices
