Devices

Direct Device Marking Guidance

FDA has issued a guidance, Unique Device Identification: Direct Marking of Devices, to assist industry, and particularly labelers, to understand agency requirements for direct marking of medical devices for unique device identification (UDI). The question-and-answer document defines some terms used in agency regulations on the UDI direct marking requirements, including how FDA interprets the term “intended to be reprocessed,” as used in the regulations.

For devices required to bear a UDI on their device label, the guidance says, the UDI regulation requires a UDI direct marking on a device if the device is intended to be used more than once and intended to be reprocessed before each use. As explained in the rule preamble, direct marking requirements apply to devices that are intended to be used for months or years, sometimes many years. Because such devices are intended to be reprocessed and reused, they will inevitably be separated from their original labels and device packages, the guidance says. Direct marking helps to ensure the adequate identification of such devices through their distribution and use.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome