What impact does the US FDA requirement for the use of an all numeric “YYYY-MM-DD” date format in UDI have on the format or use of the GS1 date-related AIDC technology Application Identifiers [e.g., AI(11) Production Date, AI(17) Expiration Date, etc.]?

There is no impact on the use of GS1 date-related AIDC technology Application Identifiers [e.g., AI(11) Production Date, AI(17) Expiration Date, etc.]. Background & Rationale:

1. The US FDA UDI regulation of 24 September 2013 selected a date format to be placed on the label “consistent with international standards and the requirements of the European Union and other nations.”
2. The US FDA UDI final rule provides that all “dates on medical device labels intended to be brought to the attention of the user” must be presented as a fixed length, eight (8) digit, all numeric field composed of 4 digits for the year (YYYY), two digits for the month (MM) and two digits for the day (DD) or “YYYY-MM-DD”. For example for the “October 15, 2013” would be represented “2013-10-15”. The dashes (or “hyphens”) between the digits are mandatory as noted in the FDA final rule.
3. The US FDA has further instructed that a day must be part of this format and cannot be blank or zero filled. (See section 801.18)4. In the recorded & noted discussion concerning date formats, the FDA stated : “Thus the specified use of YYYY-MM-DD for “dates on medical device labels intended to be brought to the attention of the user” does not affect the format or use of those dates when represented in AIDC technology.”