FDA Finalizes Guidance on Convenience Kit UDI Marking

Regulatory NewsRegulatory News | 25 April 2019 |  By 

The US Food and Drug Administration (FDA) issued final guidance Thursday to provide medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits.

The guidance finalized the 2016 draft version of the document, developed by FDA’s Center for Devices and Radiological Health and its Center for Biologics Evaluation and Research. Combination products and in vitro diagnostics subject to labeling requirements fall outside of its scope, the final guidance clarified.

The draft and final versions are largely similar, although the final guidance includes additional clarifications on the difference between a convenience kit and a medical procedure kit for the purposes of the UDI regulations.

“FDA recognizes that the interpretation of terms provided in this guidance may mean that fewer medical procedure kits are ‘convenience kits’ for purposes of the UDI regulations, which may impact the assembly and packaging of medical procedure kits that are not ‘convenience kits,’” the agency added to the draft guidance. “Nevertheless, FDA believes that the interpretation of the term ‘convenience kit’ in this guidance document is appropriate.” A new definition on the term “medical procedure kit” was also added. The definitions for “convenience kit,” “packaged together” and “end user” were slightly revised.

The final guidance’s Q&A list was shortened to six versus the eight included in the draft. Redundant questions were deleted. In terms of how much variation is allowed, the final guidance added a new detail. “It is up to the labeler to determine when a change to a particular model or version of device results in a new model or version of the device,” the answer to the second question added to the draft.

The UDI regulations have faced certain hurdles over the past few years in the road to implementing a system nationwide. They aim to aid in adequately identifying devices throughout distribution and use.

Final guidance


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