Guidance: FDA Not Recommending Specific Data Capture Tech for UDI
Manufacturers implementing unique device identification may choose a barcode for their Automatic Identification Data Capture technology, or they can use “any other technology that serves the same objectives,” new FDA guidance clarifies.
The agency is not specifying what AIDC technologies should be used, “because the most appropriate technology will vary considerably depending on the type of device and its intended uses,” the guidance says. The FDA also notes that technologies are likely to change over time.
The FDA recommends that devicemakers contact their FDA-accredited issuing agency for information on the AIDC system it uses. Non-barcode technologies, such as RFID or near-field communication, will not be as obvious to an end user, the agency notes.
If the AIDC technology is not visible on the device label or package, then the label or package must alert the user about the technology. However, the FDA doesn’t recommend any specific method for doing this.
Written in question-and-answer format, the guidance aims to address questions frequently received by the FDA’s UDI Help Desk.
The guidance stresses that labelers are responsible for determining whether device upgrades or variations constitute different models or versions of the products and, hence, a new device identifier. Changes in the value of certain attributes within the Global UDI Database device record that, by law, cannot be altered will also indicate a new device requiring a new UDI. A new device record will be required to represent the new version/mode.
The FDA frequently fields questions on whether a UDI can be affixed to a device via a sticker, rather than etching or laser marking, when direct marking is required. While the FDA is not recommending a particular approach, because that would require it to define normal usage and cleaning procedures for all devices, the direct mark must be “as permanent as the normal life expectancy of the device” and capable of withstanding normal usage and cleaning processes for the product, the guidance says.
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