Medical Device Manufacturer vs. Specification Developer

[SylvieS]

Hello,
US Company A is the MD device owner and holds the associate 510k & Company B out of the USA manufactures the Medical Device.
Company A kits the devices with its accessories, packages, and labels.

=> Shall company A be considered Manufacturer or Spec Developer ?

 

[EBD]

In the United States I would say you would register your company A as the Specification Developer and Repackager/Relabeler. Company B would then register and list the product as the manufacturer. We do something similar at our company but our manufacturer is in another country. We get finished devices then put them all together and relabel them and this is how we are registered with the FDA. Hope that helps.

 

[SylvieS]

However - which company would you put next to the manufacturer symbol - A or B ? Specification developer or the (contract) manufacturer ?

 

[EmiliaBedelia]

Company A should be listed on the label if they are the device "owner" who is placing the device on the market under their name.


For the US, the manufacturing location does not need to be listed on the label.