FDA issues draft guidance on UDI convenience kits

Editor's Note

The Food and Drug Administration (FDA) on January 4 issued a draft guidance: “Unique Device Identification [UDI]: Convenience Kits—Draft Guidance for Industry and Food and Drug Administration Staff.” The document outlines the FDA’s interpretation that the term “convenience kit,” as defined by 21 CFR 801.3, applies solely to two or more different devices packaged together for the convenience of the user. 

Under 21 CFR 801.30(a)(11), individual devices packaged in a convenience kit are excepted from UDI labeling requirements, provided a UDI is on the label of the immediate container of the convenience kit.

Since publication of the UDI final rule, the agency has determined that interpreting the term “convenience kit” to include implantable devices and instruments provided by the labeler as nonsterile before use would be inconsistent with the exception at 21 CFR 801.30 and the UDI final rule.  Comments on the draft will be received for 90 days.

Today the FDA released a draft guidance document, " Unique Device Identification: Convenience Kits - Draft Guidance for Industry and Food and Drug Administration Staff ".