FDA Proposes Limiting Definition of Convenience Kits for UDIs

The FDA is proposing a new definition for “convenience kits,” narrowing the meaning of the term for two or more different medical devices packaged together.

Under the proposal — which comes in draft guidance on unique device identification requirements — the term convenience kits applies to the devices if they are intended to remain packaged together and not replaced, substituted, repackaged or sterilized before reaching an end user.

In a final rule published in September 2013, the FDA had stated that medical procedure kits — including orthopedic procedure kits — are convenience kits. However, the agency now has determined that interpretation is not appropriate, since the devices are intended to be removed from their packaging for a surgical procedure.

When a kit is not intended to be altered prior to use, the UDI on the label of the immediate container serves to adequately identify the devices through distribution and use, the FDA explains. However, when the devices are not intended to remain packaged together, the UDI on the label of the immediate container may not follow the group of devices until end use.

As a result, prepackaged devices — such as non-sterile orthopedic device trays and reusable devices packaged together — would no longer meet the definition of the term convenience kits. However, first aid kits and anterior cruciate ligament disposable kits would still be considered convenience kits.

“FDA believes that there are significant benefits to requiring UDIs on devices included in medical procedure kits, such as more rapid identification of adverse events and more rapid, more efficient resolution of device recalls involving these devices,” the draft guidance says.

Comments are due by April 4. Read the draft guidance here: www.fdanews.com/01-16-FDA-UDI.pdf. — Jonathon Shacat