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 )