Proprietary name of a device

[manali.shah.1990]

I am a regulatory consultant for a company manufacturing insulin glargine pen injector and we are planning to submit a BLA submission with FDA for its approval.

We have a query about the proprietary name of the device.

As our final product is a biologics/device combination. We will have a proprietary name for the device, like XXXX pen.

Do we need to have this proprietary name for device approved before BLA submission?
Or in the BLA submission, it is okay for us to include a draft proprietary name or even not include one for the device itself?

Please let us know your valuable inputs on the above query.

 

[chris1price]

If it is a biologic/device combination product under 21CFR Part 4, and you are following a cGMP based streamlined approach, then there would be no requirement to give the device a separate proprietary name.