The draft guidance document titled “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products” released by the FDA in June 2024 provides industry stakeholders with key recommendations on essential drug delivery outputs (EDDOs) for drug delivery devices and combination products. EDDOs are critical to the design process and essential in ensuring accurate drug delivery to the target site. The guidance outlines the process for identifying, verifying, and validating these outputs to maintain device functionality and reliability throughout its lifecycle.
The document includes specific recommendations for identifying EDDOs, offering examples for devices such as prefilled syringes and autoinjectors. Verification and validation processes are discussed, including preconditioning and design verification testing, to confirm that EDDOs meet design requirements. Additionally, the guidance addresses the regulatory framework and the importance of quality control strategies to ensure consistent drug delivery performance.
For regulatory submissions, the guidance specifies the data and information required for investigational, marketing, and post-market change applications, aiming to improve performance consistency and streamline device development. Although the document does not cover all aspects such as biocompatibility or cybersecurity, it directs users to additional FDA resources for those requirements. The guidance provides recommendations rather than enforceable rules, allowing for flexibility in meeting regulatory standards, as its primary goal is to facilitate the development of effective and safe drug delivery devices.
Read the full guidance here.