FDA UDI compliance dates

The deadline for the Food and Drug Administration’s Unique Device Identifier (UDI) timeline is here. The first FDA UDI compliance date is Sept. 24, 2014, all labeling and packaging of Class III devices need to be in compliance with new FDA UDI format. Some of the requirements for the Sept. 24, 2014 milestone date include:

• All Class III Stand alone software and devices licensed under the Public Health Service Act.
• The dates on labels must be formatted as YYYY/MM/DD.
• Data for these devices must be submitted to the Global UDI Database (GUDID)

Other dates to remember are Sept. 24, 2015. This date calls for labels and packages of implantable life-supporting and life-sustaining devices. This also includes:

• Life-supporting/life-sustaining Stand-Alone Software must have UDI
• Life-supporting/life-sustaining devices must have UDI as permanent mark if it is to be used more than once and reprocessed before each use.
• Dates on labels must be formatted as YYYY/MM/DD
• Data for these devices must be submitted to GUDID

This process is not simple. If you are new to the industry, you have to contact an accredited agency and to produce device identification codes. According to Gayle Purtich, “Next, the medical device manufacturers’ working groups must identify a database to store device and product data and assign unique codes to all applicable items. From there, the manufacturer is responsible for labeling both the device and its packaging with the machine and human-readable alphanumeric codes, including direct part marking, when applicable,”

There are three accredited agencies that can help create device identification codes.

• GS1 (www.gs1.org)
• Health Industry Business Community Council (HIBCC) (www.hibcc.org/)
• International Council for the Commonality in Blood Banking Automation (ICCBBA) (www.iccbba.org)

Zebra Technologies vice president, David Coons, answered some questions about the FDA changes. Below are a few excerpts from the posts originally found here and here.

“Q: My company already uses barcode labels. Are we compliant?

A: Maybe, but probably not. Compliance involves the printing of a properly formatted label with a Device ID and Product ID in both human and machine readable formats. The UDI is NOT a code that is self-generated or invented by your company. The code must be approved by the FDA and issued by one of three companies that have received special FDA accreditation. In addition, the Device ID must be registered in the FDA’s Global Unique Device Identifier Database (GUDID) before it may be used on a UDI label. Unless your company has satisfied all the requirements, you are not UDI compliant.”

“Q: Will I need to redesign my labels?

A: Yes—It is very likely that you will need to redesign your labels. The UDI, in both human readable and machine readable form (typically a barcode), must be added to each label. Additionally, some of the current information on your labels may need to be reformatted to meet the UDI requirements. Many companies are finding that adding the UDI is difficult on smaller pre-existing labels. This means that some labels must be redesigned to make better use of space and/or use smaller fonts. Another option is to use a larger label.”

Who can help make this a smooth transition?

Huzzard Systems has solutions to help you with a seamless transition. We offer on-demand label  systems; Thermal transfer printers, UL recognized label material and ribbons. Huzzard also offers label design software and integration to make your transition to FDA regulations simple, efficient and painless!

Above is a label that is in compliance with the new FDA regulations. We can help meet your compliance challenges. Contact us by email info@huzzard.com or call us at (800) 321-9094 or (920) 257-4357.