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Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002 –

The Identification of the Manufacturer of Medical Devices – on the label.

Section 301 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), signed into law by President Bush on October 26, 2002, amends 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 that identifies the manufacturer. The amendment becomes effective on April 26, 2004 (21 U.S.C. 352(u)) for devices introduced or delivered for introduction into interstate commerce after that date.

This draft guidance is to advise that, the agency, in the exercise of enforcement discretion, does not intend to object if a manufacturer has not yet fully implemented the changes required by section 301 of MDUFMA for devices introduced or delivered for introduction into interstate commerce after April 26, 2004, the effective date of the provision, for a period of up to 18 months after FDA issues final guidance on its interpretation and implementation of section 301.

To review the whole document please visit the FDA website at:

http://www.fda.gov/cdrh/comp/guidance/1217.html

.S. AGENT SECTION

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