FDAnews Device Daily Bulletin

FDA ISSUES GUIDANCE ON AMENDED LABELING REQUIREMENTS

May 1, 2006
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The FDA has issued guidance on updated labeling requirements for single-use devices to comply with the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which was amended in 2005. The amended provision requires manufacturers to include a prominent and conspicuous manufacturer's mark on single-use devices.

MDUFMA requires a device, or an attachment to the device, to "bear prominently and conspicuously the name of the manufacturer, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer," the guidance states. This labeling provision applies to all devices and all device manufacturers.

The guidance identifies the circumstances in which the name, abbreviation, or symbol of the manufacturer of an original device is not "prominent and conspicuous."

The amended provision was limited to reprocessed single-use devices (SUDs) and the manufacturers who reprocess them. MDUFSA no longer sets forth requirements for original equipment manufacturers unless they also reprocess SUDs, and the manufacturer who reprocesses the SUD may identify itself using a detachable label on the packaging of the device, the guidance says.

The guidance, "Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended-Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices," can be viewed at http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0401-nad0002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0401-nad0002.pdf).