d/b/a doing business as and the FDA

[supadrai]

Hi Everyone,

Our company imports medical devices to the U.S. (medical gloves) and one of our initial importers has registered a "doing business as" for their corporation, which has no similarities to the company name.

Is this a problem?

Are there pitfalls?

I'm worried primarily about mislabeling and the changeover to the new packaging - but what else???

Thank you!

 

[v9991]

....registered a "doing business as" for their corporation, which has no similarities to the company name.

pl. elaborate...
is he importing bulk and distributing it?
is he importing bulk, and re packing/labelling?
etc?


hope you have already referred .,
Who Must Register, List and Pay the Fee


SUBCHAPTER H--MEDICAL DEVICES
PART 807 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

 

[akp060]

Hello Cove Members,
I have a related question here. In the case of a corporation (Let's say XYZ Inc.) having a DBA name (say, ABC Corp.), where devices D1, D2 nd D3 were cleared under ABC Corp. (which was previously the actual corporate name) and devices D4 and D5 are now manufactured under XYZ Inc. (with ABC corp. now being the DBA name and XYZ Inc. being the actual corporate name), should ABC Corp. now update is facility name to XYZ Inc. as the Manufacturer (assume that XYZ Inc. designs and develops the product)? If yes, case which names should be used for the devices D1, D2, and D3 for labeling and Medical Device Reporting purposes?

 

[v9991]

Hello Cove Members,
I have a related question here. In the case of a corporation (Let's say XYZ Inc.) having a DBA name (say, ABC Corp.), where devices D1, D2 nd D3 were cleared under ABC Corp. (which was previously the actual corporate name) and devices D4 and D5 are now manufactured under XYZ Inc. (with ABC corp. now being the DBA name and XYZ Inc. being the actual corporate name), should ABC Corp. now update is facility name to XYZ Inc. as the Manufacturer (assume that XYZ Inc. designs and develops the product)? If yes, case which names should be used for the devices D1, D2, and D3 for labeling and Medical Device Reporting purposes?

it requires little clarity here...,
in above case,
MA for D1-D2-D3 are seemingly held by ABC Corp. ( which later became DBA )
D4, D5 is manufactured by XYZ ( which belongs to aBC which is now DBA), so who is the MA holder?
us XYZ part of ABC corp ( which is now changed to DBA?)

logically, there two points here.,
A. its probably easier to work this way.,
whoever is the Marketing authorization (MA) holder, need to have an SOW/MSA/Quality agreement with the other constituent whether it is design and development OR, manufacturing or distribution etc.,
so in above case, assuming ABC is MA holder for all, then ensure the necessary agreements in place with necessary oversight.
else, if XYZ is is MA holder, then the agreements get little tricky of 3 products going responsibilities in one way and for later 2 products going other way.

B. updating the details of manufacturing / MA holder
one would assume two actions
1. notifying change in names ABC --> DBA
2. notifyi ng the change in association for XYZ ( ABC --> DBA )

 

[akp060]

D4, D5 is manufactured by XYZ ( which belongs to aBC which is now DBA), so who is the MA holder?

@v9991 Thank you for the reply and I am sorry for receiving the response notification much later. MA for D1 to D3 were under the initial corporate name ABC Corp., and at this point XYZ Inc. was ABC Corp's DBA name. When D4 and D5 were designed and developed, the DBA and corporate names swapped and at this point D4 and D5 are yet to be listed (so there are no MA for D4 and D5, but since the names swapped and XYZ Inc. is now the corporate name is presumably the MA holder). The question in bold font is based on this presumption.

Coming to the proposed solutions, please see my questions below:

1. whoever is the Marketing authorization (MA) holder, need to have an SOW/MSA/Quality agreement with the other constituent whether it is design and development OR, manufacturing or distribution etc.,

   Per my understanding, XYZ Inc. and ABC Corp. are the same entity only differing only by the virtue of legal name vs DBA name. Are you suggesting that ABC Corp. and XYZ Ince. are two distinct legal entities, and hence the need for the suggested agreement?

2. 2. notifyi ng the change in association for XYZ ( ABC --> DBA )

   Does this imply notifying the swap of corporate name with DBA name?
3. How does the agreement and the notification answer the question (in my query) related to labeling and Medical Device Reporting?