Relabeler for patent expired product - design control responsibilities?

Q

QualityDean

Registered
#1
#1
We want to contract with a manufacturer to make a product whose patent has expired, and relabel with our company name. No design spec changes. Product is 510(k) exempt, Class II. Product has been on the market since the 1960s. Manufacturer is using specs from expired patent product, not my company's specs. Who is responsible for Design Controls? Or, do we only need to have a Quality Control Agreement with Manufacturer? I'm having a hard time finding guidance on how we should proceed.
 
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shimonv

shimonv

Trusted Information Resource
#2
#2
An intersting situation...
Expired patent documents is not counted as design output and their is no legal owner for them anymore.
I would suggest that you assume the responsibility for design controls and create spaces (based on the patent) using your own company templates.
The contract manufacture will use your controlled documents for manufacturing, and you will monitor their performance.

Shimon
 
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