FDA Wants Input on Details of UDI Direct Marking Draft Guidance

FDA's draft guidance on direct marking of medical devices asks industry to weigh in on the definition of device "reprocessing."

Marie Thibault

June 25, 2015

2 Min Read
FDA Wants Input on Details of UDI Direct Marking Draft Guidance

Marie Thibault

As part of its unique device identifier rule, FDA has published draft guidance, "Unique Device Identification: Direct Marking of Devices," on direct marking for reprocessable medical devices. 

Direct marking of a device is required, according to the UDI rule, when the medical device "is intended to be used more than once and intended to be reprocessed before each use." But FDA is looking for guidance from industry on what should be considered "reprocessed" and what the definition of "intended to be used more than once" should be.

In a Federal Register notice announcing the draft guidance, FDA specifically asks for industry's thoughts on three items:

  • "However, the UDI Rule does not define “intended to be used more than once” and “reprocessed.” FDA’s interpretation of these terms is included in this draft guidance, but FDA seeks additional information on its current definition of “reprocessing” for purposes of UDI direct marking requirements."

  • "FDA is concerned that devices intended to be used more than once tend to be separated from its original label during reprocessing, making accurate identification of devices difficult or impossible. Should the definition of “reprocessing” for purposes of UDI direct marking requirements include cleaning alone without subsequent disinfection and/or sterilization of the device?"

  • "What public health benefits would be served by requiring a UDI direct marking to be affixed to devices intended to be reused for which reprocessing instructions include cleaning only and not disinfection and/or sterilization?"

The UDI rule has led to some questions and Citizen Petitions from companies about details of the requirement. Though the question of whether cleaning should count as reprocessing is open to discussion, FDA uses the draft guidance to clarify several topics. These topics include details such as:

  • devices made and labeled before the compliance date have three years following the compliance date to meet the labeling requirements

  • FDA does not require a specific method of marking the device

  • the direct marking does not need to change if the UDI on the device packaging/labeling changes

Enhance your medtech knowledge by attending MEDevice San Diego, September 1–2, 2015, in San Diego.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie


About the Author(s)

Marie Thibault

Marie Thibault is the managing editor for Medical Device and Diagnostic Industry and Qmed. Reach her at [email protected] and on Twitter @MedTechMarie.

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