Devices

Key Changes in Final UDI Guidance

A CDRH 11/30 Webinar reviewed key changes to the recently finalized guidance Unique Device Identification: Direct Marking of Devices. UDI (unique device identifier) program regulatory policy analyst Christina Savasaar said the agency received 17 comments on its draft guidance from external stakeholders and published the final guidance 11/17.

The guidance applies to devices required to bear a UDI on their label that are also intended to be used more than once, and intended to be reprocessed. It does not apply to implants, which are not required to be directly marked.

“One key change from the draft guidance to the final guidance,” Savasaar said, “is the definition of ‘intended to be reprocessed’ has been narrowed. In the draft guidance, we considered a device that is intended to be cleaned and either sterilized or disinfected before each use to be ‘intended to be reprocessed.’ In the final guidance, we consider a device intended to be reprocessed only if it is intended to undergo high-level disinfection and/or sterilization before each use or between uses. This does not include a device intended only to be cleaned between uses on different patients or intended to undergo lower levels of disinfection without subsequent high-level disinfection or sterilization before each use or between uses.”

Savasaar said another change in the guidance is addition of an enforcement discretion policy pertaining to devices that were consigned or loaned to hospitals or other healthcare facilities or with a sales representative in the field pending sale prior to their applicable UDI label compliance date. “To the extent that these devices are required to comply with UDI regulatory requirements for labeling, direct marking, or date format,” she said, “FDA does not intend to enforce compliance with such requirements.”

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