Hello! I have a regulatory question and I am finding mixed answers as I am reading through the available guidances and forums.
Current Situation:
Company A is the 510k owner and manufacturer of device 'X' which is provided solely to Company B for commerical distribution. Company A has complete ownership of the DHF, DMR, and completes all packaging, sterilization, and labeling with their information prior to shipping to Company B for distribution. Company B does nothing other than distribute the device and they are the sole distributors of device 'X'.
Now, Company A has asked Company B to submit a new 510k for device 'X'. Important to note this is NOT a transfer/sale of a 510k. Company A still wants to own their 510k for manufacturing other devices. The new 510k to be submitted by Company B will use Company A's 510k as SE. The new 510k will allow Company A to become the owner and liable for device 'X'. Company B will continue to use Company B as the contract manufacturer of device 'X' including packaging and sterilization. Labelling will be changed to Company A as the now owner of device 'X'.
My question is, as Company B, what do I need to include in the submission? I do know that we will be responsible for the DHF and DMR and Company A is happy to give all documentation to support the new 510k and transfer of liability. Company A will also update their registeration as a contract manufacturer and contract sterilizer. Other than that, just follow the traditional 510k outline and call it a day?
Thank you for your help!
Current Situation:
Company A is the 510k owner and manufacturer of device 'X' which is provided solely to Company B for commerical distribution. Company A has complete ownership of the DHF, DMR, and completes all packaging, sterilization, and labeling with their information prior to shipping to Company B for distribution. Company B does nothing other than distribute the device and they are the sole distributors of device 'X'.
Now, Company A has asked Company B to submit a new 510k for device 'X'. Important to note this is NOT a transfer/sale of a 510k. Company A still wants to own their 510k for manufacturing other devices. The new 510k to be submitted by Company B will use Company A's 510k as SE. The new 510k will allow Company A to become the owner and liable for device 'X'. Company B will continue to use Company B as the contract manufacturer of device 'X' including packaging and sterilization. Labelling will be changed to Company A as the now owner of device 'X'.
My question is, as Company B, what do I need to include in the submission? I do know that we will be responsible for the DHF and DMR and Company A is happy to give all documentation to support the new 510k and transfer of liability. Company A will also update their registeration as a contract manufacturer and contract sterilizer. Other than that, just follow the traditional 510k outline and call it a day?
Thank you for your help!