FDA’s UDI Draft Guidance Aims to Help with Rule Compliance

By MedTech Intelligence Staff

The agency clarifies the UDI rule for labelers and accredited issuing agencies.

FDA just released a draft guidance to assist with compliance with the Unique Device Identifier (UDI) rule. The UDI rule requires that most medical device labels and packages have a UDI that is easy to read and is in automatic identification and data capture technology (AIDC) forms. UDI’s are issued under a system run by FDA-accredited issuing agencies (IAs). The agency has currently accredited three IAs, which are located in New Jersey, Arizona and California.

The draft, Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI), clarifies the following for labelers and FDA-accredited IAs to aid in compliance with the UDI rule:

  • Two forms of a UDI
  • Content of the UDI (including data delimiters that identify specific data elements within the UDI)
  • Order of data in a UDI and UDI carrier (the means to convey the UDI and any non-UDI elements in easily readable plain-text and AIDC forms)

FDA is accepting comments on the draft guidance for the next 60 days.

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