M
Hey All,
I have a question concerning the licensing of an 510k to another manufacturer. Manufacturer A owns a 510k and is currently private labeling the 510k device to Manufacturer B. Manufacturer B decides it wants to manufacturer the device themselves under Manufacturer A?s 510k. Is it as simple as Manufacturer A granting Manufacturer B the right to manufacturer the device under their name through a signed agreement? Or would Manufacturer B need to file a new 510k to manufacturer the same device? I look forward to your guidance.
- D
I have a question concerning the licensing of an 510k to another manufacturer. Manufacturer A owns a 510k and is currently private labeling the 510k device to Manufacturer B. Manufacturer B decides it wants to manufacturer the device themselves under Manufacturer A?s 510k. Is it as simple as Manufacturer A granting Manufacturer B the right to manufacturer the device under their name through a signed agreement? Or would Manufacturer B need to file a new 510k to manufacturer the same device? I look forward to your guidance.
- D