Regulatory Open Forum

Hi Everyone!

I need some community input on this question:

If the DOM is on the label, does it have to be in the barcode (even though the LOT/SERIAL number is also on the label and that is the means by which we track the products)? 

Please advise!!!!!

I keep getting conflicting information from FDA and other device manufacturers. 

You are asking about a production identifier, the date of manufacture. If it is on the label in easily readable plain text, it must be the proper FDA format, YYYY-MM-DD. It must also be in the AIDC, the bar code. In the AIDC, the date of manufacture must be in the format prescribed by the Issuing Agency. (This will be different from the easily readable plain text format.)

In addition, if you have a lot number or serial number on the label in easily readable plain text it must also be in the AIDC using the Issuing Agency specifications.

UDI provides identification information only, not tracking information, so you must include the applicable identification information.

Yes, if the Date of Manufacture is on the label, it must go in the PI of the barcode. But remember that DOM is not always required on the label.