21 CFR 810 - Medical Device Recall Authority - Contract Manufacturing

[Schkund]

When a contract manufacturer produces a finished medical device for a customer/design owner, is one specific party expected to initiate the recall, or is it based on internal agreement between the design owner and the contract manufacturer?

I work for on the contract manufacturing side and am wondering if our procedure should involve direct reporting to the FDA, support for the customer who is conducting the recall, or both.

 

[chris1price]

Firstly, I would check your Quality Agreement (or similar contract) with the customer. This should clearly specify who is responsible for these actions. If you don't have such a contract, I would write one quickly. In practice, I would expect the customer, or whoever has listed the product with FDA to be responsible for recall. Your procedure should support the customer, and you'll probably want to perform a mock action at least once per year.