FDA Releases Unique Device Identifier Draft Guidance

Zachary Brennan of the Regulatory Affairs Professional Society (RAPS) outlined the guidance from the Food and Drug Administration (FDA) about the expected content and forms for the Unique Device Identifier (UDI) for medical device manufacturers and distributors that are coming into effect.

UDI Background

A UDI is composed of:

  • A device identifier
  • One or more Production Identifiers (PIs)
  • Data delimiters for DI and PIs (delimiters are sets of characters that identify specific data elements with an encoded data string)

UDI contents must adhere to certain formats and include specific data. The FDA also wants the presence of AIDC technology (Automatic Identification and Data Capture, which refers to the non-manual methods of how data is collected and stored) to be noted on labels or packaging.

The rules also include an establishment of a UDI system from a 2013 published guidance that can completely identify and track devices through distribution. UDI’s must be issued by an FDA accredited agency (specified in 21 CFR Part 830 Subpart C) and must conform to international standards.

In 2014, the FDA began phasing in UDIs by adding tracking tags to certain Class III devices. Implants, life-supporting and life-sustaining devices began using UDIs in 2015. Class II devices must start complying later this year and by 2018, all Class I and non-classifiable devices will need to be in compliance.

Assessing the Draft Guidance

Now that the draft has been released, stakeholders have the option to comment on it for the next 60 days. The FDA has made it a point that the AIDC form of UDIs should be scanned whenever possible to minimize recordkeeping errors and manual transcriptions.

AIDC technology is being promoted to more rapidly and accurately acquire data, record it, and aid the retrieval process for patients and health care professionals alike.

A plain-text, readable failsafe should be available too if the UDI cannot be captured or the AIDC cannot be scanned. The text must follow the FDA’s definition of “plain-text” and be displayed below or near the electronic form of data.

 Those who handle the scanning and recording aspect of the UDIs should test and verify the UDIs to make sure that they are generated in a reliable and readily available way. There are multiple forms that the data can be written in and the FDA does allow for labelers to best determine how to utilize AIDC technology. This gives labelers more flexibility and eases the compliance burden.

UDI Content

The FDA specifies that a UDI is composed of a singular DI and contains one or more of the five PIs listed in 21 CFR Part 801.3 and 801.40(b) along with the data delimiters. UDIs must be submitted to a Global Unique Device Identification Database (GUDID). This is a web database where device submissions are uploaded to the GUDID Health Level 7 Structured Product Labeling interface (HL7 SPL) using the XML file format.

Part 801.3 defines AIDC technology and the information required:

  • Combination products or Convenience kits must be identified (two or more medical devices packaged together for simplified patient use)
  • Device packages must contain quantities of a version or model
  • Expiration dates if specified
  • Human cells, tissues, cellular, or tissue-based product (HCT/P) products classified as devices spelled out in 1271.3(d) that don’t meet the criteria in 1271.10(a) must have UDIs
  • Any implant that stays for more than 30 continuous days needs a UDI

Part 801.3 lists much more information, definitions, and criteria in regards to UDIs and should be used as a go-to resource for clarification on the new guidance. The FDA has also made a helpful table with key compliance dates available. This is the culmination of the Food and Drug Administration Amendments Act of 2007, whereupon the establishment of the UDI started.

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