Looking for somebody to shed some light here....
After reviewing the "Who Must Register and List" table at the FDA website, my company would fall into the "Contract manufacturer who does NOT commercially distributes for the specifications developer." According to the table, my company does not have to register or list.
Now we have received a FAQ list from the FDA which for "Who is required to list their devices?" says ".....In addition, contract manufacturers and contract sterilizers (......) must also now list at the time of their annual registration." It doesn't differentiate between commercial distributors or non-distributors.
Anybody have any input from their own recent experience?
Also, it looks like the FDA is charging now to register every year (an incremental scale at that too). That's one reason I don't want to register or list if I don't have to.
After reviewing the "Who Must Register and List" table at the FDA website, my company would fall into the "Contract manufacturer who does NOT commercially distributes for the specifications developer." According to the table, my company does not have to register or list.
Now we have received a FAQ list from the FDA which for "Who is required to list their devices?" says ".....In addition, contract manufacturers and contract sterilizers (......) must also now list at the time of their annual registration." It doesn't differentiate between commercial distributors or non-distributors.
Anybody have any input from their own recent experience?
Also, it looks like the FDA is charging now to register every year (an incremental scale at that too). That's one reason I don't want to register or list if I don't have to.