美国医疗器械注册 FDA 510K注册变更的条件

A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements 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