Ownership of FDA registered establishment changing - what to do?

rthompson

Starting to get Involved
#1
Greetings All,

The ownership of our FDA registered establishment will be changing very soon. All else will remain the same including the facility location, QMS, employees, etc. Only the companies tax ID # (EIN) will be changing.
What do I need to do as far as notification of the FDA? Is it as simple as re-registering our establishment using the new EIN? Is there any other updates required regarding the devices that we manufacture?
I know this is somewhat of an unusual question and I thank you all in advance for any assistance.
Best,
Rob
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Is it as simple as re-registering our establishment using the new EIN? Is there any other updates required regarding the devices that we manufacture?
The DRLM site https://www.access.fda.gov/oaa/ provides a function entitled "Transfer Ownership of Devices or Facilities". I believe that function is the appropriate way to indicate a change of ownership when an existing facility will remain open and already-marketed products will continue to be available.

I don't know specifically how changes to the responsible-party name for a 510(k) listing are handled, but I assume the above function is integrated with that requirement as well.

If you have more complex technical/legal questions on this issue, perhaps you should call DSMICA and make sure that your business actions are consistent with the official requirements.
 

Al Rosen

Staff member
Super Moderator
#3
Greetings All,

The ownership of our FDA registered establishment will be changing very soon. All else will remain the same including the facility location, QMS, employees, etc. Only the companies tax ID # (EIN) will be changing.
What do I need to do as far as notification of the FDA? Is it as simple as re-registering our establishment using the new EIN? Is there any other updates required regarding the devices that we manufacture?
I know this is somewhat of an unusual question and I thank you all in advance for any assistance.
Best,
Rob
I don't recall the EIN being collected.
 
M

MIREGMGR

#5
Depending on how you pay, the EIN may be collected during the fee payment process for a 510(k), on Form 3601 line 1.1.

I don't specifically recall, but it might also be collected during the payment process for Establishment registration or renewal.
 
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