Opportunity
Federal Register #2026-22203
FDA Revised Draft Guidance on Drug-Delivery Device Performance
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 30, 2026
Respond By
January 28, 2027
Identifier
2026-22203
The U.S. Department of Health and Human Services’ Food and Drug Administration (FDA) issued revised draft guidance on drug-delivery performance characteristics. - Government entity: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA); no sub-agency or office is identified. - Notice type: Revised draft guidance, not a procurement opportunity or contract award. - Scope: Devices and combination products with device constituent parts intended to deliver human drugs, including biological products. - Guidance focus: Recommends how to develop and organize performance information and data for investigational, marketing, and postmarket change applications. - OEMs, vendors, products, and services: None identified; no purchase quantities or part numbers are provided.
Description
The FDA announces the availability of a revised draft guidance for industry on essential drug-delivery performance characteristics for devices intended to deliver drugs and biological products. It revises and replaces the draft guidance announced in 2024 and covers devices and combination products with device constituent parts intended to deliver a human drug, including a biological product. The guidance recommends how to develop and organize performance information and data for investigational, marketing, and postmarket change applications, aiming to improve consistency and support regulatory review. Comments are due January 28, 2027.