Unique Device Identification: Convenience Kits; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Unique Device Identification: Convenience Kits; Draft Guidance for Industry and Food and Drug Administration Staff.'' This proposed guidance document is intended to outline the Agency's current thinking that for purposes of Unique Device Identification (UDI) labeling and data submission requirements, the term ``convenience kit'' 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. This draft guidance is not final nor is it in effect at this time. When finalized, this guidance document will constitute a change in policy.