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USFDA: Guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products

The U.S. Food and Drug Administration, yesterday announced the release of a draft guidance, Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products.

 Essential Drug Delivery Outputs (EDDOs) are the design outputs necessary to ensure delivery of the intended drug dose to the intended delivery site.

In this guidance, key aspects of drug delivery performance information are addressed for devices and combination products that include device constituent parts, intended to deliver human drugs, including biological products.

FDA’s guidance describes the outputs of device design that are crucial to establishing and assessing drug delivery performance Also this guidance includes recommendations for the information and data to submit in investigational, marketing, and post-market change applications.

This guidance focuses on the information and data submitted to the FDA regarding EDDOs for devices and device components of CDER-led and CBER-led combination products intended for administering human drugs, including biological products. Examples of such products include syringes, injectors (like autoinjectors and on-body injectors), infusion devices (such as infusion pumps), nasal sprays, inhalers, nebulizers, and vaginal systems.

In developing EDDOs, there are three primary processes: identification, control, and maintenance and the following steps are useful in identifying EDDOs

  1. Design Outputs: Define intended use and design inputs to identify design outputs.

  2. Drug Delivery Design Outputs: Specify outputs related to drug delivery, such as dose and delivery method.

  3. System Level Design Outputs: Identify outputs crucial for final product performance.

  4. Device Dependent Design Outputs: Define outputs dependent on device design, ensuring controlled product manufacture.

This guidance covers a high-level overview of the processes involved in identifying, verifying, and validating EDDOs. It serves as a roadmap for the detailed instructions that follow, ensuring manufacturers understand the critical steps required.

This comprehensive guidance document ensures that drug delivery devices are developed, tested, and maintained to deliver consistent and accurate dosing, safeguarding public health and meeting regulatory standards. For further details, please refer to the full guidance document available here.


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