What are the agencies authorized by the FDA to issue UDIs?

The FDA currently authorizes three major agencies, GS1, HIBCC, and ICCBBA, to issue UDI codes. Under 21 CFR 830 subpart C, these agencies are responsible for acting on behalf of the FDA, reviewing specific information on UDI applications submitted throughout the U.S., and evaluating the applications in accordance with the regulations. Considering the burden of the introduction of UDI identifiers on small and medium-sized businesses, the following are exempt from or in lieu of UDI labeling under regulation 21 CFR 830 subpart B:

1. 3-year exemption for dates of manufacture and labeling that are earlier than the date of compliance with the UDI

2. Exemption of Class I medical devices from the GMP requirements

3. Devices that have been individually Individually packaged single-use devices that are not intended for commercial distribution, and for which the packaging is removed at the time of use

4. Devices intended solely for research, teaching, or analysis, and not intended for clinical use

5. Customized devices, as defined in Chapter I 812.3 b of the regulations

In addition, according to the official website of the UDI FDA will gradually improve the UDI over the next 7 years after the UDI is issued. In addition, according to the UDI FDA website, the UDI system will be refined over a period of seven years to make it more effective. The exemptions and application fees will be adjusted, and registrants should follow the regulations periodically.

Will the form of the UDI be different for different UDI-issuing organizations? According to the latest 2016 FDA-issued UDI form instructions document, UDIs issued by different authorizing agencies will be different. Take the example of a GSI-issuing organization:

In the example above, the numbers between 01 and 11 represent the device identifier, (11) followed by the time of manufacture, (17) followed by the time of expiration, (10) followed by the device lot number (21) followed by the serial number.

Example of UDI format compared to that issued by HIBCC:

In this UDI, the + followed by the symbol represents the LIC + Product or catalog number (PCN), the /$$ followed by the symbol represents the time of expiration (YYJJJJ format) + the device lot number, the /S symbol followed by the character represents the supplemental serial number, the /16D followed by the digit represents the time of manufacture, and the /16D followed by the digit represents the serial number. The number following the /S symbol represents the supplemental serial number, and the number following the /16D symbol represents the date of manufacture.

Compare this to the example of the UDI format issued by the ICCBBA:

In the example shown in the table above, the symbols after "=/" represent the device identifier, the symbols after "=," represent the serial number, and the symbols after "=" represent the serial number, the symbols after "=" represent the serial number, and the symbols after "=" represent the serial number. The symbol after "=" represents the place identifier, the number after "=>" represents the expiration time, the number after "=)" represents the production time, and finally The symbol after "&,1" represents the MPHO lot number.

It is important to note that the ICCBBA's UDI form for blood bags differs from that for medical devices in general.

A more detailed explanation of the UDI format can be found in the FDA's UDI format clarification document

Although there are different formats for UDIs issued by the authorizing agencies, one-dimensional barcodes, two-dimensional barcodes, and radiofrequency identification tags (RFID) are all recognized for all three types of carriers.