FDA UDI Question - Class II Medical Device

#1
Hi,

My company is developing a class II medical device to be marketed in the US. I have a question regarding the FDA UDI regulation, specifically 21 CFR § 830.20. Does our company need to go through an accredited issuing agency and have them create a UDI specifically for our device? Or can our team create a UDI ourselves by applying the same format that the accredited issuing agency uses?
What confuses us is the wording in the 21 CFR § 830.20 where it states "A unique device identifier (UDI) must: (a) Be issued under a system operated by FDA or an FDA-accredited issuing agency;...."
What "..system operated by the FDA.." are they referring to here? Since they write "or" it seems like they are referring to some alternative to the accredited issuing agency?

Thanks in advance.
 
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#2
can our team create a UDI ourselves by applying the same format that the accredited issuing agency uses?
I don't think it is possible. You will need to register your company with the FDA-accredited issuing agency to use their format.
a system operated by FDA
Perhaps it is talking about the FDA labeler codes and to my understanding it will not be assigned to any new manufacturer. If there is any other system then I am not aware of it.
accredited issuing agency
I have only seen and worked with FDA-accredited issuing agency (more specifically GS1) in order to comply with the UDI requirements. There are three such agencies so far, check this link. If you go for GS1, after registering with them you will get your company prefix which will be a part of the DI. With your company prefix, you can then create the complete DI by following their requirements.
 
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