Guidance for Industry and Food and Drug Administration Staff: Food and Drug Administration and Industry Actions on Premarket Notification Submissions: Effect on Food and Drug Administration Review Clock and Performance Assessment; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment." This guidance describes how FDA will assess its performance in the premarket notification (510(k)) program relative to the goals that accompany the authorization of medical device user fees. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).