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
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