Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Expedited Review of Premarket Submissions for Devices." This guidance describes how the agency is applying the statutory criteria and the additional criteria identified in a letter accompanying the user fee legislation to meet the new performance goals for expedited premarket approval applications (PMAs). This guidance also describes FDA's expedited review procedures for premarket notification submissions (510(k)s), product development protocols (PDPs), and de novo classification actions. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).