Zdrowie i gospodarka · 05/11/1998

Guidance for Industry on General/Specific Intended Use; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry on General/Specific Intended Use.'' FDA developed this guidance to satisfy a new section of the Federal Food, Drug, and Cosmetic Act (the act), which was added by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This new section directs the agency to issue guidance explaining the general principles used by FDA in determining when a specific use may be added to a legally marketed device using premarket notification (510(k)) procedures and when a specific use triggers the need for a premarket approval (PMA) application.