FDA

FDA’s UDI Draft Guidance Aims to Help with Rule Compliance

By MedTech Intelligence Staff
FDA

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FDA just released a draft guidance to assist with compliance with the Unique Device Identifier (UDI) rule.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FDA is accepting comments on the draft guidance for the next 60 days.

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