Hi,
If the change/s in the product leads to the below points these are reported to authorities, authorities study these changes may recommend the changes dependently.
- 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