Transfer of 510(k) Ownership between Companies

P

Pauling

#1
Hi, all

A nonUS medical device manufacturer, Company A, submitted
a 510(k) for a medical device that was marketed in the US.
The owner of the company A decided to close the company
and founded Company Y, which was also outside the US.
Questions as following:
1. If company A would like to transfer 510(k) ownership, how to transfer?
who could do this job?If US agent of company Y could do this job, or it should deal by US agent of company A?

2. After transferring, if the 510(k) ownership in the fda database will be showner as Company Y? If not, what other record could prove that?

3. After transferring, what's obligation should Company A bear for the products had marketed in US? Could these obligations transfer to company Y? What doc or record should transfer to COMPANY y at the same time with transferring the ownership of 510(k)?

Any comment will be appreciated! Thanks in advance!
 
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M

MIREGMGR

#2
The general process for transfer of ownership of a 510(k) is described - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS; the example is specific to latex examination/surgical gloves, but the process is generally applicable.

Note however that for non-US companies there might be legal questions related to their home nation, and perhaps international issues.

Also note that shortcomings in 510(k) transfer are being considered at high levels within FDA. See the 39th slide in this recent seminar presentation: www. fda. gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM201345.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

It might be worthwhile to call FDA DSMICA to get their comments on the particular circumstances involved. My guess would be that they might refer the question to an FDA legal staffer, such as Deborah Wolf.
 
Last edited by a moderator:

bio_subbu

Super Moderator
#3
Hi, all
A nonUS medical device manufacturer, Company A, submitted
a 510(k) for a medical device that was marketed in the US.
The owner of the company A decided to close the company
and founded Company Y, which was also outside the US.
Questions as following:
1. If company A would like to transfer 510(k) ownership, how to transfer?
who could do this job?If US agent of company Y could do this job, or it should deal by US agent of company A?
Company A can transfer the 510(k) to Company B. The transfer contract is a legal matter rather than a regulatory issue and It should probably signed by the owner (Presidents and/or CEOs) of the both companies and either U.S. agent can set up the transfer.
2. After transferring, if the 510(k) ownership in the fda database will be showner as Company Y? If not, what other record could prove that?
The FDA’s 510(k) database can’t be changed, but there is a possibility to do de-list the company A from the FDA registration site, if company A is going out of business. This can be done someone from the Company A, who has right to access the FURLS accounts.

3. After transferring, what's obligation should Company A bear for the products had marketed in US? Could these obligations transfer to company Y? What doc or record should transfer to COMPANY y at the same time with transferring the ownership of 510(k)?

Any comment will be appreciated! Thanks in advance!
It depends on the companies transfer agreement. If Company A wants their obligations to transfer to Company B, and Company B agrees to it, the post market obligations for devices sold by Company A can be transferred to Company B.

The Design History File (DHF), the 510(k) documentation and the Device Master Record should go to Company B. Company A should retain photocopies of the same records. If Company B is taking over servicing and complaint handling for devices sold by Company A. Company B should also have the Complaint files, service records and batch history records of any devices during the lifetimes of the devices.

Please see 21 CFR 820.180, (b) Record retention period it specifies that “All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer”. Company A should probably retain records for two years after selling the 510(k) to Company B.
 
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Y

yana prus

#5
Hi Pauling,

2. After transferring, if the 510(k) ownership in the fda database will be showner as Company Y? If not, what other record could prove that?

After transfering, you still could see to whom was originally given the 510(k) clearance in the 510(k) summary, but the 510(k) ownership and the applicant name in the FDA 510(k) database will be shown as Company Y.

Here is the example:

the original 510(k) clearance was given to company C. Company L. has purchased one of the divisions of the Company C. and now company L. appears as an 510(k) ownership and an applicant in the 510(k) database of FDA for some of company C. products:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122524

Legal ownership of the 510(k) clearance can be very important for the customs aspects.
To avoid problems when importing a device with a transferred 510(k) ownership, FDA recommends that a copy of the specific information relating to the ownership sale or transfer accompany all shipments to the United States. This could be a simple one-page document detailing the transfer transaction. If the owner is not able to provide the documentation of transfer, FDA may request the owner to submit a 510(k).

The new owner should list the device according to 21 CFR part 807 and the previous owner should delete its device listing.

The new owner should maintain information documenting the transfer of ownership of a 510(k), including any legal transactions that took place, in its 510(k) files.

Hope that helps,

Yana
 
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T

tallu

#6
This is old thread but I give a shot without starting a new one because my issues is related to 510k ownership.

If company A a have ownership to clearance K000001. And they also have clearance K000002 which is Special 510k for previous clearance.

My question is that if company sells the ownership of K000001 is it related any how to K000002?

Comapany A still have the ownership to K000002, right?
 
E

evilchilli_420

#7
Tallu: Companies usually sell ownership of products and all 510(k)'s related to that product line will be included in the package unless the contract talks otherwise. I do not know of a scenario where a company would sell a 510(k) and not the special 510(k) associated with the same product.


Thank you.
 
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