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# Revised Guidance on Drug-Delivery Device Performance Requirements
- URL: https://www.fdaweb.com/revised-guidance-on-drug-delivery-device-performance-requirements/
- Published: 2026-10-29T20:00:00.000Z
- Updated: 2026-10-30T00:06:11.000Z
- Author: David McFarland
- Tags: Devices

FDA has issued a revised a 6/2024 draft guidance outlining the performance characteristics manufacturers should evaluate, validate and control for medical devices used to deliver drugs and biological products, including drug-device combination products.

The [guidance](https://www.fda.gov/media/179545/download?ref=fdaweb.com), *Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products*, intends to clarify expectations for testing and controlling device performance and align the recommendations with FDA's revised Quality Management System Regulation (QMSR).

It introduces the term *essential drug delivery device performance characteristics* (EDDCs) to describe system-level functions necessary to deliver the intended drug dose to the intended administration site. Manufacturers should identify these characteristics and establish specifications, acceptance criteria, verification and validation procedures, and control strategies to ensure consistent performance throughout the product lifecycle, the agency says.

The recommendations apply to a broad range of products, including prefilled syringes, autoinjectors, on-body injectors, infusion pumps, nasal sprays, inhalers, nebulizers and vaginal drug-delivery systems.

FDA distinguishes essential system-level performance characteristics from lower-level component attributes and user-dependent functions. For example, glide force may qualify as an EDDC for a prefilled syringe, while injection time and injection depth may be essential characteristics for an autoinjector.

The draft also addresses the performance information manufacturers should submit in investigational and marketing applications, including INDs, IDEs, NDAs, ANDAs, BLAs and medical device premarket submissions.