Aimed at providing medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits, FDA has finalized its guidance “Unique Device Identification: Convenience Kits Guidance for Industry and Food and Drug Administration Staff ” on April 26, 2019.

Convenience Kits: FDA issues final guidance on UDI marking

The unique device identification system regulations (21 CFR 801.20) require that the label and each device package of every medical device distributed in the United States bear an UDI to facilitate their identification throughout distribution and use.

The difference between a convenience kit (considered a device in itself, therefore required to bear an UDI only on the label of its container) and a medical procedure kit (where each device must comply with applicable UDI labelling, data submission, and direct mark requirements) is illustrated by way of a few concrete examples:

  • a single use disposable medical procedure kit is considered a convenience kit. It contains two or more different Medical Devices packaged together for the convenience of the user, and respects the requirement to (a) remain packaged together and (b) not be replaced, substituted, repackaged, sterilized, or otherwise processed or modified before being used by an end user;
  • a non-sterile orthopedic kit is not considered a convenience kit. The reason is that each device contained in is removed from its packaging to undergo sterilization prior its use by an end user.

The guidance does not apply to combination products and in vitro diagnostics subject to labelling requirements.