以下产品变更需要重新申请510(K)
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
