FDA Modernization Act of 1997: Guidance for the Device Industry on Implementation of Highest Priority Provisions; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``FDA Modernization Act of 1997: Guidance for the Device Industry on Implementation of Highest Priority Provisions; Availability.'' This guidance, generally referred to as the ``Day-1 guidance'' summarizes FDA's strategy for implementing the highest priority provisions of the FDA Modernization Act of 1997 (FDAMA) as it relates to the regulation of medical devices. The agency requests comments on this guidance.