Timeframe for Product Label Update after Company Name Change

[ajbera3]

The company (LLC) that owns us is changing their name. Once I make the update to our FDA registration, how much time do we have to update our product labels, packaging, and IFU?

A colleague believed it was a 90 day time frame, but I cannot locate an FDA regulation with that precise information. Any guidance would be appreciated.

Thanks in advance!

 

[Ajit Basrur]

Re: Timeframe for product label update after company name change?

The company (LLC) that owns us is changing their name. Once I make the update to our FDA registration, how much time do we have to update our product labels, packaging, and IFU?

A colleague believed it was a 90 day time frame, but I cannot locate an FDA regulation with that precise information. Any guidance would be appreciated.

Thanks in advance!

Would this thread help - How to notify FDA of change of ownership?

 

[ajbera3]

Re: Timeframe for product label update after company name change?

Ajit,

First, thanks for your help in relocating this thread.

Second, I have read through the thread you linked and it does not answer my question.

I have managers and colleagues pressing me for a precise timeframe and I am unable to provide an answer. I find it hard to believe that the FDA would leave it entirely open-ended, but if I tell my managers that there is no deadline then it's entirely possible they wouldn't update the labels on a product line until the next version was released, whenever that may be.

If there is no deadline, if it falls under the FDA's ambiguous "least burdensome" approach that leaves it entirely up to us, that's an acceptable response. I'd just like to be certain before I report back to the various functional groups.

 

[MIREGMGR]

Re: Timeframe for product label update after company name change?

I am not aware of a specific regulation or guidance on your question.

My contextual understanding is that for a reasonable time following such a change of name/ownership, FDA is willing to accept technically incorrect information on the labeling as long as it is assured that an end user is not hampered from making timely contact with the actual responsible manufacturer or other party, for instance to report an adverse event or make a performance complaint.

This could be accomplished by means of maintaining directory entries, mailing addresses, on-line URL forwarding and the like so that any inquiry directed to the old name is assuredly and immediately forwarded to the company.

Such a scenario can hardly be avoided in the case of product that is in the field already, or "in the pipeline". My understanding is that FDA extends that forbearance to include additional manufactured product within a reasonable bound, as long as you can show that end user contact has been assured.