FDA Revises Draft Guidance on Drug Delivery Device Performance Requirements
Key Points
- FDA issued a revised draft guidance, “Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products,” replacing the July 1, 2024 draft.
- The guidance covers drug delivery performance information for devices and combination products delivering human drugs, including biologics.
- It aims to improve consistency in applications and streamline development, lifecycle management, and regulatory review.
The FDA has announced the availability of a revised draft guidance for industry entitled “Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products.” This revised draft guidance revises and replaces the draft guidance entitled “Essential Drug Delivery Outputs Intended to Deliver Drugs and Biological Products” announced in the Federal Register on July 1, 2024 (89 FR 54470). In accordance with its mission of protecting, promoting, and advancing public health, 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. This guidance is meant to provide recommendations for development and organization of device drug-delivery performance information and data to improve the consistency of this information in applications and to facilitate transparency and predictability in development and regulatory review. According to the agency, the guidance is intended to facilitate and streamline development and lifecycle management of drug delivery devices.
Visit www.fda.gov for more information.
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