J
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
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