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FDA Lot Code format requirements

katastic2908

Involved In Discussions
#1
Good Afternoon,

Is anyone aware if the FDA has any special lot code format requirements? Currently our lot codes include a few special characters (-hyphen and +plus). We use an app called UDI Check to check our barcodes, it's a really useful app.

Our lot codes with the special characters come back with an error message and when I spoke to the creators of the App they told me that it's the FDAs system that can't read the barcode because the +sign tells the FDA there is more information to follow and it was recommended that we remove the special characters from our lot code.

I was wondering if anyone has heard of that before, or is aware of any particular FDA lot code format requirements.

Thank you
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
§830.20 Requirements for a unique device identifier.

A unique device identifier (UDI) must:

(a) Be issued under a system operated by FDA or an FDA-accredited issuing agency;

(b) Conform to each of the following international standards:

(1) ISO/IEC 15459-2, which is incorporated by reference at §830.10;

(2) ISO/IEC 15459-4, which is incorporated by reference at §830.10; and

(3) ISO/IEC 15459-6, which is incorporated by reference at §830.10.

(c) Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at §830.10.
 
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