Change of contact person

[Jennifer27]

Hi!

We received additional information letter from the FDA on our 510k submission. But our current consultant is very unresponsive, so we are thinking o] changing the contact person.

Can an applicant/manufacturer change the official correspondent of the 510k submission in the middle of review. Is there a formal process that needs to be followed to change the official contact person, or anyone can email the FDA reviewer saying from now on I will act as the company's official correspondent.

Look forward to your advise

Best,
Jen

 

[Jennifer27]

Please help.

 

[Ronen E]

Hi!

We received additional information letter from the FDA on our 510k submission. But our current consultant is very unresponsive, so we are thinking o] changing the contact person.

Can an applicant/manufacturer change the official correspondent of the 510k submission in the middle of review. Is there a formal process that needs to be followed to change the official contact person, or anyone can email the FDA reviewer saying from now on I will act as the company's official correspondent.

Look forward to your advise

Best,
Jen

Hi,

The official correspondent and the named contact person do not have to be the same. I have been named the contact person as an independent consultant, while the official correspondent was someone from the company. The official correspondent is relevant to official correspondence )), such as the SE/NSE letter.

If you already have an open line of communication with the reviewer, I don't see any issues with contacting them, explaining your motive and asking that another person would be addressed in all email correspondence (the current named contact can still be copied). If anything more official is necessary, they will let you know about it.

Cheers,
Ronen.

 

[Jennifer27]

Thank you Ronen!