Yes-- until the clearance letter is issued, you can work with the lead reviewer on several items related to the submission. I had marketing want to change the name of a device while in the midst of a review and so I wanted the clearance letter to state the new name rather than the name under which it was submitted. When I asked, that was no problem for the reviewer. In that case, I requested changing the name when responding to the questions in the request for additional information. All I needed to provide to the reviewer was a revised indications for use form (3881) with the new name (although obviously all labeling was revised subsequently).
In like manner, one does not need to complete establishment registration until after a company's first 510(k) or PMA is cleared/approved, so you can put the new address in at that time.
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Thomas Lawson PhD
Principal Consultant
El Cerrito CA
United States
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Original Message:
Sent: 22-Aug-2022 18:24
From: Anonymous Member
Subject: Address Change during 510k review
This message was posted by a user wishing to remain anonymous
Hi,
What is the process for changing the address of the manufacturer during the 510k review process?
This is our first 510k and we have not yet registered the facility with the FDA.
Is this as simple as notifying the lead reviewer on company letterhead?