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.