Dear Forum,

My company just acquired a smaller medical device company, with just one product on the marked.

The current 510(K) for this product is now registered on the "acquired" company, which does not exist anymore.

I´m uncertain as to how this should be handled. Would it be enough to inform FDA of the acquisition and state that this product now belong to us?

(We are already a medical device manufacturer no no additional certification would be necessary)


best regards
t.

This is probably more Al's domain, but I would believe that you would simply need to inform FDA, and provide some sort of evidence of the organizational structure.

Dear Forum,

My company just acquired a smaller medical device company, with just one product on the marked.

The current 510(K) for this product is now registered on the "acquired" company, which does not exist anymore.

I´m uncertain as to how this should be handled. Would it be enough to inform FDA of the acquisition and state that this product now belong to us?

(We are already a medical device manufacturer no no additional certification would be necessary)


best regards
t.You have left out a lot of details. Is the device going to be produced in the same facility and under the old company name? Is the name of the device changing? Look at Transfer of 510(k) Ownership (http://www.qrasupport.com/transfer-510.html#transfer-510)

Thanks Al,


I´ll provide some details:

1)Both the former manufacturer and we are located in Europe, but the US distributor is the same.

2)The production/assembly/service of the device is transferred to our facilities.

3) Name, labeling etc stays the same.

The information in the link didn´t say anything about this.


best regards
t.

Thanks Al,


I'll provide some details:

1) Both the former manufacturer and we are located in Europe, but the US distributor is the same.

2) The production/assembly/service of the device is transferred to our facilities.

3) Name, labeling etc stays the same.

The information in the link didn´t say anything about this.

best regards
t.

Hello,

Look at this thread: http://elsmar.com/Forums/showthread.php?t=20165

Stijloor.

Thanks Al,


I´ll provide some details:

1)Both the former manufacturer and we are located in Europe, but the US distributor is the same.

2)The production/assembly/service of the device is transferred to our facilities.

3) Name, labeling etc stays the same.

The information in the link didn´t say anything about this.


best regards
t.I think you will need to update your establishment registration. On Form 2891 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/FDA-2891.pdf) there is a place(box 6.3) to indicate the old company has merged with a new company. I think your US Agent can handle this.