October 11, 2005

Manufacturers that reprocess single-use devices (SUDs) must attach to the products a prominent and conspicuous mark identifying the firm's name or recognized symbol, according to a new FDA draft guidance that offers practical suggestions on what is necessary for a corporate identifier to be recognized during ordinary use.

A manufacturer's mark will be considered prominent and conspicuous based on four factors: available space, contrast, font or graphic readability and meaning, says the guidance, published Oct. 11 in the <i>Federal Register</i>.

Under the 2005 Medical Device User Fee Stabilization Act (MDUFSA), the labeling provision on corporate marks, which previously applied to all manufacturers, was limited to reprocessed SUDs and the manufacturers who reprocess them, the guidance says. The change also applies to original equipment manufacturers that reprocess SUDs.

In addition, MDUFSA states that if the original device, or an attachment to it, does not prominently and conspicuously bear the name of the original device manufacturer -- or a generally recognized abbreviation of the name, or a unique and generally recognized symbol identifying the company -- the reprocessor of the SUD may identify itself using a detachable label on the packaging of the device.

Comments to the guidance are due within 30 days of the <i>Federal Register</i> publication date. The draft guidance, "Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended -- Prominent and Conspicuous Mark of Manufacturers on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," is available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0401-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0401-gdl0001.pdf).

(http://www.fdanews.com/ddl target=_blank)