510(k) Submitter Name Change question - Only the name of the company is changed

[celia4237]

If the 510(k) already get approved, and then the name of the submitter is changed, i mean, only the name of the company is changed, will FDA change the 510(k) letter?

For example, our company name is A, and we submit the 510(k) submission for device X and get cleared, the submitter of this 510(k) is company A. The name of company A appears on the 510(K) SE letter and 510(k) database.
Now our company name is changed from A to B, but we still want to sell the device X, however, the 510(K) SE letter is still under company A's name and when search the 510(k) database, the K number is still under company A's name,.

So i want to ask if the K number of the device X still belong to company B, if not, do i have to change the submitter's name of the 510(k) from company A to B, how can i do?

[MIREGMGR]

Our experience has been that the FDA will not change information in the public version of the database, no matter why it needs changing...even if it's incorrect because of an entry error of theirs.

The internal version of the database, on the other hand, can be changed. There is an option in the DRML database, where you go to list products and establishments, pertaining to change of ownership.

I have no idea why this is the policy, but that's been our experience. We've had one glaring FDA data entry error for twenty years now, and it's not changed yet...and not because we haven't asked.

[celia4237]

However, i think it is not a transfer of ownership, because company A and company B is indeed one entity. Only the name is changed.

What do you think?

[MIREGMGR]

Contact FDA DSMICA and ask them.

[celia4237]

FDA tell me that for the change of company name, i only need to update the registration and listing information, and the original 510(k) number and SE letter will remain unchanged.

[Marc]

Originally Posted by celia4237

FDA tell me... <snip>

Thanks for letting us know!

[harry]

Just a comment on the practices of the 'Registrar of Companies' here.

If your company known as ABC applied to change its name to XYZ, you will be issued with a new certificate where it will be stated: XYZ Company formerly known as ABC company. Traceability and legal responsibilities therefore remain intact.

I've seem people stating: ABC company (now known as XYZ company) or XYZ company (formerly known as ABC company).