Are Design History Files required by "Product Labelers" in order to ship in the USA?

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I work for a medical device company. We purchase several products from an Original Equipment Manufacturers (OEM) supplier and have those products labeled with our company name and other pertinent information. In doing so, it is my understanding that make us the "Legal Manufacturer" of those products. If so, here is my question.

In FDA Title 21 Part 820, Section 820.30 (j) it talks about Design History Files: "Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part."

My question is this: In the requirement above the FDA MDR refers to Each Manufacturer - does that pertain to Product Labelers (like us) or just the OEM's? Trying to obtain the DHF information from the OEM on hundreds of products, doesn't seem practical, when we are not the OEM but simply a Product Labeler. How does a Product Labeler deal with this requirement when we want to ship in the USA?

Please advise...


Quite Involved in Discussions
It's all in the details. Exactly, how do you label the product? Your brand, I get it. But, does the label say "Manufactured for <your firm>" or does it say "Manufactured By <your firm>". You might also say "Distributed By <your firm>".

"Distributed By" and "Manufactured for" would be the least burdensome to your firm from a regulatory compliance standpoint. Your contracts (including quality agreement) would clearly define who owns what depending on how you choose to brand and label the product.

Edit: Your quality agreement would specifically define who owns what regarding DHF. Your firm, for example, would control design of branding label images while they would control the rest of the DHF.
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