Proprietary name of 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.

 

[ECHO]

Ideally you would have your proprietary name in your submission but there are ways to update it if need be.

I think this FAQ might help.

Here are also instructions on how to update it later

 

[Jim Wynne]

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.

BLA = Biologic License Application (I had to look it up). Please spell out abbreviations on first use.

 

[Randy]

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.

Unique concept for the most correct answer that you need.........Why not check with the FDA itself for the most correct information?

Development & Approval Process (CBER)