Regulatory Open Forum

For my company's device listing, can we change the proprietary name of a device listed with FDA ?
Thanks,

Yes, you can change the proprietary name of a device listed with the FDA. According to 21 CFR 807.25(e), the information required for each device listed includes the proprietary or brand name(s) under which each device is marketed. If you need to update the proprietary name of a device, you can do so using the FDA electronic device registration and listing system as mentioned in 21 CFR 807.28(e). Any changes to the listing information, such as a new proprietary name, must be made using the electronic device registration and listing system at the time the listing is updated or reactivated.<o:p></o:p>

For my company's device listing, can we change the proprietary name of a device listed with FDA ?
Thanks,

Yes, you can change the proprietary name of a device listed with the FDA. According to 21 CFR 807.25(e), the information required for each device listed includes the proprietary or brand name(s) under which each device is marketed. If you need to update the proprietary name of a device, you can do so using the FDA electronic device registration and listing system as mentioned in 21 CFR 807.28(e). Any changes to the listing information, such as a new proprietary name, must be made using the electronic device registration and listing system at the time the listing is updated or reactivated.<o:p></o:p>

For my company's device listing, can we change the proprietary name of a device listed with FDA ?
Thanks,

Thank you Michaela.
21 CFR 807.28(e) refers to a discontinued device being resumed.
For an active device (510(k) cleared) that is active, can we change the proprietary name?
Will the system ask for a new product code / new UDI ?
Thanks,

Yes, you can change the proprietary name of a device listed with the FDA. According to 21 CFR 807.25(e), the information required for each device listed includes the proprietary or brand name(s) under which each device is marketed. If you need to update the proprietary name of a device, you can do so using the FDA electronic device registration and listing system as mentioned in 21 CFR 807.28(e). Any changes to the listing information, such as a new proprietary name, must be made using the electronic device registration and listing system at the time the listing is updated or reactivated.<o:p></o:p>

For my company's device listing, can we change the proprietary name of a device listed with FDA ?
Thanks,

A name change for a medical device does not automatically trigger the assignment of a new product code or a new Unique Device Identifier (UDI). However, if the FDA determines that the name change is substantial and requires a new submission, they may assign a new product code or request updates to the UDI database

Thank you Michaela.
21 CFR 807.28(e) refers to a discontinued device being resumed.
For an active device (510(k) cleared) that is active, can we change the proprietary name?
Will the system ask for a new product code / new UDI ?
Thanks,

Yes, you can change the proprietary name of a device listed with the FDA. According to 21 CFR 807.25(e), the information required for each device listed includes the proprietary or brand name(s) under which each device is marketed. If you need to update the proprietary name of a device, you can do so using the FDA electronic device registration and listing system as mentioned in 21 CFR 807.28(e). Any changes to the listing information, such as a new proprietary name, must be made using the electronic device registration and listing system at the time the listing is updated or reactivated.<o:p></o:p>

For my company's device listing, can we change the proprietary name of a device listed with FDA ?
Thanks,