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Medical Devices / Regulatory Affairs

FDA Clarifies Labeling Identifier Rules for Convenience Kits

April 30, 2019
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The FDA considers first aid and other “convenience” kits a single device for regulatory purposes, the agency said in final guidance.

The agency is hoping to simplify unique device identifier regulations for so-called convenience kits, which had required different labels for each of the unique devices in every kit.

Federal rules define “convenience kit” as “two or more different medical devices packaged together for the convenience of the user.” The regulators now consider that definition “to mean a device that contains two or more difference medical devices packaged together and intended to remain packaged together.”

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