FDA publishes final guidance for UDI direct marking requirements

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David Lennarz, Registrar Corp.

FDA UDI compliance UDIs medtech

[Image courtesy of Christiaan Colen on Flickr, per Creative Commons 2.0 license]

The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime. This is known as UDI direct marking. The FDA recently published a final guidance on requirements for the direct marking of medical devices.

According to the guidance, the device labeler is responsible for direct marking a device with a UDI in either human readable or automatic identification and data capture (AIDC) format. The method of marking, such as etching or attaching a permanent tag, is decided at the labeler’s discretion and must account for wear from the intended use of the device.

What is new in the final guidance?

FDA recently conducted a webinar explaining the key differences between the final guidance of this regulation and the draft guidance published in 2015.  Notable changes include:

  • FDA established that a device is “intended to be reprocessed” if it is intended to undergo high-level disinfection and/or sterilization before or between each use. High-level disinfection is defined in this guidance as a process in which a sterilant kills “all forms of microbial life, except for large numbers of bacterial spores.”
  • FDA emphasized that implants, which are not mentioned in the draft guidance, do not fall within the scope of UDI direct marking regulation.
  • FDA does not intend to enforce UDI labeling and direct marking compliance for devices that were consigned or loaned to a healthcare facility before the devices’ respective UDI labeling compliance dates. This also applies to devices in the possession of a sales representative pending sale under the same conditions.
  • In June 2017, FDA issued a letter outlining intentions to extend the UDI labeling compliance date for covered class I and unclassified devices to September 24, 2020. During the webinar, the Agency clarified that it does not intend to enforce direct marking requirements for these devices until September 24, 2022.

Remaining compliance dates for UDI direct marking

Unless exempt from UDI direct marking requirements, the compliance date for class I and unclassified devices is as established above, and the compliance date for direct marking of class II devices remains September 24, 2018, as outlined in the UDI final rule.  Devices manufactured before their respective UDI labeling compliance dates are provided three additional years to comply with labeling and direct marking requirements.

David Lennarz is VP at Registrar Corp. (Hampton, Va.).

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