Today the FDA released a draft guidance document, “Unique Device Identification: Convenience Kits – Draft Guidance for Industry and Food and Drug Administration Staff ”. This document is intended to outline the agency’s proposed interpretation that the term “convenience kit”, as defined by 21 CFR 801.3, applies solely to two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.
Under 21 CFR 801.30(a)(11), individual devices packaged within a convenience kit are excepted from the UDI labeling requirements, provided that a UDI is on the label of the immediate container of the convenience kit. The preamble to the UDI final rule expressed our thinking at the time that medical procedure kits, including orthopedic procedure kits, are convenience kits. Since the publication of the UDI final rule, we have determined that interpreting the term “convenience kit” at 21 CFR 801.3 to include implantable devices and instruments provided by the labeler in sets or trays as non-sterile and repeatedly reconfigured and sterilized (or cleaned and sterilized) prior to use would be inconsistent with the purpose of the exceptions at 21 CFR 801.30 and the UDI final rule generally. The draft guidance explains the proposed change in our interpretation of “convenience kit” and the rationale for this change.
We welcome your comments and suggestions regarding this draft guidance. The comment period will be open for 90 days.
For more information about the Unique Device Identification (UDI) System, please visit the FDA’s UDI webpage.
If you have any questions, please contact the FDA UDI Help Desk.