以下幾種情況下需要做FDA510(K) 變更   

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

• Addition of a new patient population

• Changes to 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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