Overview – FDA Draft Guidance - Essential Drug Delivery Outputs For Devices Intended To Deliver Drugs And Biologics

By Lauren Orme and Mike Ulman

The FDA has long mandated that manufacturers of drug-delivery combination products identify critical performance requirements throughout a product's lifecycle. 

In June 2024, the FDA released much-anticipated draft guidance. This document introduces and defines new terminology, clarifying the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements. This guidance doesn't cover all submission information for drug/delivery devices; instead, it focuses on performance-related outputs and their associated processes.

The draft guidance was open for comments until September 30, 2024. While a final version could take several years to publish, the current draft reflects the FDA's latest thinking. Therefore, all future submissions are expected to align with its recommendations.

Access the full article for an overview of the guidance.