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Can someone share some regulatory expertise on this? I am the 510k owner of a medical device for the US market and have contracted out the manufacturing of the device. Technically, I fit in the "manufacturer" definition of FDA (21 CFR 820.3) because I own the design but since I do not physically manufacture the product at my facility, must I have "Manufactured for" with the name of my company and address on my product labeling? I am having a problem interpreting the intent of 21 CFR 801.1(c), which states "where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device, such as, 'Manufactured for ___', 'Distributed by ___', or any other wording that expresses the facts."
I assume this clause pertains to private label manufacturers and not to manufacturers who are outsourcing part or all of the manufacturing/packaging activities. Am I correct?
Thanks,
Oscar
I assume this clause pertains to private label manufacturers and not to manufacturers who are outsourcing part or all of the manufacturing/packaging activities. Am I correct?
Thanks,
Oscar
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