US FDA revises draft guidance on drug delivery devices

The US Food and Drug Administration (FDA) has issued revised draft guidance on how manufacturers should show that devices used to deliver medicines work properly. It covers devices such as syringes, autoinjectors, infusion pumps, inhalers and nasal sprays. The revised draft replaces the 2024 version and changes the term “Essential Drug Delivery Outputs” to “Essential Drug Delivery Device Performance Characteristics” (EDDCs). The guidance refers to the key features that ensure a device delivers the correct drug dose to the intended site and explains how manufacturers should test device performance, maintain quality during manufacturing and assess changes made after a product enters the market. The draft is non-binding. Comments may be submitted until January 28, 2027.