Essential Drug Delivery Outputs for Devices Intended To Deliver Drugs and Biological Products; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products." This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of a human drug, including a biological product (herein referred to as drug delivery devices). The guidance describes FDA's recommendations related to the device design outputs that are essential for establishing and assessing drug delivery performance. FDA is providing recommendations for development and organization of device drug-delivery performance information to improve the consistency of this information in applications and submissions. The guidance is intended to facilitate and streamline development of drug delivery devices.