Draft Guidance for Industry and FDA Staff; Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002-Identification of Manufacturer of Medical Devices; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled "Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002--Identification of Manufacturer of Medical Devices." Section 301 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) requires that a device, or an attachment to the device, 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. Section 301 becomes effective on April 26, 2004, for devices introduced or delivered for introduction into interstate commerce after that date. This draft guidance provides that the agency, in the exercise of enforcement discretion, does not intend to object if a manufacturer has not yet fully implemented the changes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, for a period of up to 18 months after FDA issues final guidance on its interpretation and implementation of section 301. This draft guidance is nei