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: Guidance for Industry and FDA Staff

Issue Date: May 1, 2006
Issued by: Center for Devices and Radiological Health
Topic(s): Postmarket, User Fees, Labeling
Status: Final

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: Guidance for Industry and FDA Staff

On October 26, 2002, section 301 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) amended section 502 of the Federal Food, Drug, and Cosmetic Act (the Act) to require 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. An important revision was made to section 502(u) of the Act by the Medical Device User Fee Stabilization Act of 2005 (MDUFSA) (Public Law 109-43), which became law on August 1, 2005. MDUFSA amended section 502(u) by limiting the provision to reprocessed single-use devices (SUDs) and the manufacturers who reprocess them. Section 502(u) no longer sets forth requirements for original equipment manufacturers (OEMs), unless those manufacturers also reprocess single-use devices. Under the amended provision, if the original device or an attachment to it does not prominently and conspicuously bear the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer, the manufacturer who reprocesses the SUD may identify itself using a detachable label on the device’s packaging. The detachable label is intended to be affixed to the medical record of a patient by the user of the reprocessed SUD.

Download the Guidance Document