Make the Labeling Claim Match the Evidence
Revise a device labeling claim so it matches intended use, evidence, and adequate directions.
A package claim says the catheter accessory prevents infection, but the evidence supports maintaining a sterile barrier during insertion. Labeling should align claim scope, intended use, directions, warnings, and evidence so users know what the device does and how to use it safely. The common shortcut is letting marketing language grow from supported function to clinical outcome claim without matching evidence or directions. Narrow the claim Replace prevents infection with helps maintain a sterile barrier during catheter insertion when used according to the IFU. The revised claim fits the supported function and avoids promising a clinical outcome the evidence does…
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