FDA Consultation on Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products
On 29 October 2026, the U.S. Food and Drug Administration (FDA) published a revised draft guidance, Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products. The guidance replaces a 2024 draft and provides recommendations for identifying, verifying, validating, and controlling device characteristics essential to reliable drug delivery. It also updates recommendations on performance information and data for regulatory submissions and aligns the approach with the FDA's Quality Management System Regulation (QMSR).
Overview
Authority | U.S. Food and Drug Administration (FDA) – Office of Combination Products, CDER, CBER, and CDRH |
Date | 29 October 2026 |
Focus | Essential drug delivery performance characteristics, verification and validation, control strategies, and regulatory submissions |
Type | Revised draft guidance for industry; request for comments |
Deadline for comments | 28 January 2027 |
What is this about?
Drug delivery devices are expected to consistently deliver the intended drug dose to the intended delivery site. Reliable device performance is therefore an important consideration for the safety and effectiveness of drug products and drug-device combination products.
The revised guidance introduces the concept of Essential Drug Delivery Device Performance Characteristics (EDDCs), replacing the term Essential Drug Delivery Outputs (EDDOs) used in the 2024 draft. EDDCs are system-level characteristics that depend on the functional device design and are essential to achieving the intended drug delivery performance.
Examples may include dose accuracy, injection time, activation force, or other characteristics necessary for successful drug delivery, depending on the product and delivery technology.
The guidance applies to drug delivery devices regulated by the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER), as well as to device constituent parts of combination products for which the Center for Drug Evaluation and Research (CDER) or CBER has primary regulatory responsibility.
Covered products include prefilled syringes, autoinjectors, infusion products, nasal sprays, inhalers, nebulizers, and vaginal drug delivery systems.
The document focuses specifically on drug delivery performance. Other considerations, including biocompatibility, sterility, human factors, and cybersecurity, remain outside its scope and are addressed through other applicable requirements and guidance documents.
Consultation details
The revised draft guidance provides recommendations covering several key areas:
Identification of essential performance characteristics: Manufacturers should identify EDDCs based on device design, intended use, and product-specific characteristics. Lower-level component characteristics that are already captured by an EDDC, as well as user-dependent functions, are not considered EDDCs. The guidance provides examples illustrating these distinctions across different device types.
Performance specifications and verification: Appropriate EDDC specifications and acceptance criteria should be established and supported by relevant evidence. Verification activities should demonstrate that the final finished product meets its specifications under applicable conditions, with acceptance criteria that are clinically meaningful and appropriate for the intended use.
Preconditioning and performance testing: The guidance recommends evaluating conditions that may affect performance during storage, shipping, preparation, and use. These may include temperature, humidity, pressure, vibration, shock, and physical orientation. Testing approaches and statistical sampling plans should be tailored to product-specific risks and relevant use conditions.
Design validation and supporting evidence: Validation should demonstrate that the device meets its intended use and user needs. Depending on the product and regulatory pathway, supporting evidence may include clinical studies, pharmacokinetic or bioequivalence data, scientific literature, or comparisons with reference products or predicate devices.
Control strategies and quality management: The FDA recommends risk-based control strategies to ensure that essential performance characteristics consistently meet their specifications. These may include supplier controls, in-process controls, manufacturing process controls, and finished-product testing. The revised recommendations reflect the QMSR framework and its incorporation of ISO 13485.
Information in regulatory submissions: The guidance describes EDDC-related information for investigational applications, marketing applications, and postmarket change submissions. Recommendations address device descriptions, performance specifications, verification and validation evidence, risk management, and control strategies. The required or recommended information varies according to the regulatory pathway and applicable requirements.
Lifecycle management and product changes: Manufacturers should assess whether design or manufacturing changes affect existing EDDCs, introduce new EDDCs, or require additional verification, validation, or modifications to control strategies. The guidance also encourages early interaction with the FDA to discuss proposed EDDCs and supporting development approaches.
The draft guidance contains nonbinding recommendations and does not establish new legally enforceable requirements. Existing statutory and regulatory obligations remain in effect.
Useful links
Access the consultation materials and submission tools.
FDA Guidance Page — Essential Drug Delivery Performance Characteristics ➜ Official guidance page providing consultation information and access to the revised draft guidance PDF
Download the full revised draft guidance through the official FDA document page
Official notice announcing the revised guidance and explaining the comment submission procedures
Official docket for reviewing consultation materials and accessing the electronic comment submission process
Key timeline
Publication: 29 October 2026
Deadline for comments: 28 January 2027
Although FDA guidance documents may be commented on at any time, comments submitted by the designated deadline are intended to be considered before the agency begins preparing the final guidance.
Why this matters
The revised guidance may influence the development, regulatory assessment, and lifecycle management of a broad range of drug delivery devices and combination products. By focusing on system-level performance characteristics, the FDA aims to improve the consistency of performance information submitted during product development and regulatory review.
Of particular relevance is the connection between EDDC specifications, risk-based testing, and manufacturing control strategies. The recommendations may affect how manufacturers organize performance evidence, justify acceptance criteria, and document the continued performance of drug delivery devices throughout their lifecycle. The alignment with the QMSR also reinforces the relationship between device development, quality management, and regulatory submissions.
Stakeholders may wish to consider whether the proposed approach is sufficiently clear and practical across different drug delivery technologies and regulatory pathways. The consultation provides an opportunity to raise implementation challenges and suggest clarifications before the guidance is finalized.
Who should consider responding?
Drug delivery device manufacturers developing syringes, autoinjectors, infusion systems, inhalation devices, and other covered technologies
Pharmaceutical and biotechnology companies developing or marketing drug-device and biologic-device combination products
Regulatory affairs professionals responsible for investigational applications, marketing submissions, and postmarket changes
Product development, quality, and manufacturing teams involved in performance verification, validation, risk management, and control strategies
Component suppliers and industry associations with relevant experience in drug delivery performance and manufacturing controls
Practical implications
Stakeholders should consider:
Determining which current or planned products fall within the scope of the revised guidance
Reviewing how EDDCs are identified and distinguished from component-level characteristics and user-dependent functions
Comparing existing verification and validation approaches with the FDA's proposed recommendations, including preconditioning, sampling, and shelf-life considerations
Assessing whether current regulatory documentation and manufacturing control strategies adequately address essential drug delivery performance
Identifying implementation challenges or areas where additional clarification from the FDA may be beneficial
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