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UDI: FDA Draft Guidance

The US Food and Drug Administration (FDA) published its latest draft guidance on UDI, entitled: “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).”

The guidance, intended at this stage for comment purposes only, is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). When finalized, it will represent the current thinking of the FDA on the form and content of the UDI. It does not establish any rights for any person and is not binding on FDA or the public.

The medical device industry – both labellers, as 96 defined under 21 CFR 801.3, and FDA-accredited issuing agencies, as defined under 21 CFR 97 830.3 - can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

In this updated draft guidance, the FDA describes five major components of UDI form and content that are required to be on medical device packaging:

  • Forms of UDI
  • Disclosure of presence of AIDC technology
  • Content of UDI
  • Data delimiters
  • Order of the data represented in the UDI carrier

The FDA is seeking additional information on this issue with particular interest in receiving information relating to the following question:
Are there any additional standards, in addition to those referenced in this draft guidance, which should be used to determine the print quality of the AIDC form of the UDI?

The UDI rule began applying to Class III devices in 2014 and implantable, life-supporting and life-sustaining devices in 2015.  Class II devices will be in compliance in 2016, and Class I and non-classified devices will need to have them in 2018.

It is clear that a data-first approach is becoming a critical element of ensuring UDI compliance. Medical device organizations will require full visibility of all their data assets as well as editing tools and vision control to help maintain data integrity. Crucially, robust data validation and transparent audit tools that can supply objective evidence in the event of internal or regulatory inspections will become of increasing importance.

For more information on the FDA’s UDI program:
Download our whitepaper

Read our blog post: UDI: An inconvenience or a chance for change?

About the Author:

Warren Stacey, SVP of Sales PRISYM IDWarren-small

Warren Stacey is the SVP of Sales at PRISYM ID, responsible for leading and driving results from the global sales team. He has a detailed knowledge of the auto-ID industry with particular emphasis on label lifecycle management and production techniques.

Warren is passionate in identifying and securing new business opportunities, whilst building business within our existing global client base to create year on year revenue growth. His belief in delivering market leading products to gain customer satisfaction is infectious and result’s in PRISYM ID having an enviable blue-chip customer base which is rapidly growing.