产品发生哪些变更需要重新申请510(K)

     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