Guidance for Industry and Food and Drug Administration Staff: Compliance With the Medical Device User Fee and Modernization Act of 2002, as amended-Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "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." The Medical Device User Fee and Modernization Act 2002 (MDUFMA), as amended by the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), requires that FDA issue guidance identifying the circumstances in which the name, abbreviation, or symbol of the manufacturer of an original device is not "prominent and conspicuous." MDUFSA requires that FDA issue guidance no later than 180 days after the date of enactment (August 1, 2005).