Changing the Address in 510(K) Approved Product

Kuldeep Singh

Involved In Discussions
#1
Hi Everyone,

We would like to introduce ourselves as Manufacturer of Medical Diagnostic Equipment's namely X-Ray Machines falls under Class II product of FDA regulation. We have two units (i.e Unit I and Unit II) in our factory premises . We are plan to Approved our Unit I from FDA as per CFR 820. All the fda related products shall manufactured and shipped through this unit. But I have a question related to old products

1. As our previously 510(K) products approved with Unit II address. Can anyone suggest us , what should we do, to change the address of 510(K) approval. Is it need to special submission for address change or document rational is sufficient?
2. If document rational is sufficient , In future misshaping, Will unit II fall under FDA influence or liabilities ?

Your valuable suggestions will help us a-lot. Thanks in advance.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
The address in the 510(k) doesn't require updating after receiving the SE letter.
Addresses you need to keep the FDA updated on:
- Establishment registration & Device Listing (only facilities currently related to the device)
- Address(es) in labeling
 
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