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That was a great thought provoking response. Thank you for taking the time to articulate it. Yes, you are correct, they would NOT be considered a Contract Manufacturer and thus, not directly regulated by 21CFR820. I was using the term in the business sense and it probably confused my situation. This is why I love this forum!
Just so I have this correct..... a component manufacturer that sells to end users (not the OEM, i.e. replacement components) IS required to register and list AND is regulated by 21CFR820. But, a component manufacturer that sells to the OEM or manufactures to another companies design and only sells to that company IS NOT required to register and list and IS NOT regulated by 21CFR820. They would be obligated by the Purchasing Controls 21CFR820.50 enforced either by the OEM or the other company that owns the design for which they are manufacturing. Is this correct?
Just so I have this correct..... a component manufacturer that sells to end users (not the OEM, i.e. replacement components) IS required to register and list AND is regulated by 21CFR820. But, a component manufacturer that sells to the OEM or manufactures to another companies design and only sells to that company IS NOT required to register and list and IS NOT regulated by 21CFR820. They would be obligated by the Purchasing Controls 21CFR820.50 enforced either by the OEM or the other company that owns the design for which they are manufacturing. Is this correct?
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