Workshop: Essential Drug Delivery Output

In June 2024 the FDA released a draft guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. The draft guidance describes Agency expectations for essential drug delivery characteristics for certain medical devices and combination products and articulates an approach to identify and submit this information for FDA review. This session seeks to better understand how industry has interpreted key concepts in the guidance and explore how these concepts can be integrated into existing development, post-approval and global regulatory processes.

This will be accomplished through two sessions:
Unpacking Key EDDO Concepts: Exploration of central aspects of the draft guidance including impact to existing quality management system practices, and comparison to existing concensus standards and global requirements
• How we got from EPRs to EDDOs: design input vs. design output or give companies flexibility
• Specific topics from initial feedback:
o QMS vs ICH Q12 and inspectional impact
o Clinical validation (DV and DVal)
Envisioning the Future of EDDO: Idenfication of potential areas of refinement to the central aspects of the draft guidance to improve integration into existing development, post-approval, and regulatory processes.