Adding unclassified product to the medical device registration

N

NatVa

Nat
#1
#1
Hello all,

So we're a contract manufacturer (non-US based) and will be manufacturing an unclassified medical device for a US based company. We have FDA medical device registration for class 1 but in order to add unclassified product, is there anything else i need to ensure regulatory requirements wise?

I understand i would probably need to ask my US agent to add the unclassified product to the med device registration. Is that it or is there more to ensure compliance?

My research for this question did not help me find answers. Please advise.

Regards
N
 
I

indubioush

Quite Involved in Discussions
#2
#2
"An unclassified device is a pre-amendments device for which a classification regulation has not been promulgated. Unclassified devices require submission of a 510(k) premarket notification to CDRH. A not-classified device is a post-amendments device for which the Agency has not yet reviewed a marketing application or for which the Agency has not made a final decision on such a marketing application."

Are you talking about an unclassified device or a not-classified device?
 
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