哪些变更需要提交新的510（K）

apremarket notification (510(k)) is required when a legally marketeddevice subject to 510(k) re is significantly changed or modified indesign, components, method of manufacture, or intended use.significant changes or modifications are those that couldsignificantly affect the safety or effectiveness of the device, ormajor changes or modifications in the intended use of thedevice。

asto 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:

achange in indications for use from prescription use to  overthe counter use

addition of a new patient population

changes  the environment of use such as from professional useto 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 thepreviously 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 chemicalcomposition

changes in the antibody, detection reagents, critical reactioncomponents or conjugates for in vitro diagnostic (ivd) devices

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