On October 29, 2026, the U.S. Food and Drug Administration (FDA) issued revised draft guidance titled Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products.

The guidance addresses how manufacturers should identify, evaluate, and control device performance characteristics necessary to ensure that drugs and biological products are delivered as intended.

For medical device and combination product manufacturers, the message is clear: drug delivery performance must be defined, verified, and controlled throughout the product lifecycle, not simply demonstrated during final testing.

What FDA Is Clarifying

The revised guidance replaces FDA’s 2024 draft on Essential Drug Delivery Outputs (EDDOs), introducing the term Essential Drug Delivery Performance Characteristics (EDDCs).

These characteristics represent the critical aspects of device performance needed to deliver the intended drug dose to the intended administration site.

The guidance applies to a broad range of drug delivery technologies, including:

• Prefilled syringes and autoinjectors
• Infusion pumps and on-body injectors
• Inhalers and nebulizers
• Nasal sprays and other drug delivery systems

FDA’s recommendations focus on establishing performance specifications, verifying and validating those specifications, developing control strategies, and presenting supporting evidence in investigational, marketing, and postmarket change applications.

The revised draft also reflects FDA’s updated Quality Management System Regulation (QMSR), reinforcing the connection between regulatory submissions and quality system processes.

Why Performance Requirements Begin With Design Controls

An effective drug delivery system must do more than function correctly under ideal conditions. It must consistently perform as intended throughout manufacturing, distribution, storage, and use.

For example, an autoinjector may need to meet defined requirements for injection time, needle insertion, and drug delivery performance. A prefilled syringe may require specifications for glide force to help ensure reliable administration.

These requirements should be established early in development and connected directly to design inputs, risk assessments, verification protocols, and acceptance criteria.

Without this alignment, manufacturers risk discovering performance gaps late in development, especially since when correcting them can be expensive and may affect regulatory timelines.

Verification Must Reflect Real-World Conditions

One important aspect of FDA’s revised guidance is its emphasis on evaluating performance under conditions that devices may reasonably experience throughout their lifecycle.

Temperature, humidity, pressure, vibration, physical orientation, and other environmental factors can affect drug delivery performance.

FDA discusses the importance of appropriate preconditioning to simulate conditions encountered during shipping and storage before evaluating whether performance specifications are met.

For manufacturers, this highlights the need for verification and validation strategies that account for realistic product handling and use conditions.

Testing that demonstrates acceptable performance under controlled laboratory conditions may not fully address the risks associated with real-world exposure.

Manufacturing Controls and Change Management Matter

Drug delivery performance can be influenced by much more than the final device design.

Material properties, component tolerances, supplier changes, manufacturing processes, and assembly conditions may all affect critical performance characteristics.

Consequently, manufacturers should evaluate whether their control strategies adequately address the factors that influence drug delivery.

This includes maintaining effective:

• Supplier qualification and material controls
• Manufacturing process validation
• Design and process change control
• Risk management documentation
• Verification and validation records
• Ongoing product performance monitoring

For combination products, coordination between drug, device, quality, and regulatory teams is especially important when assessing changes that could affect delivery performance.

A seemingly minor component or process modification may have broader implications for product performance and regulatory compliance.

What Manufacturers Should Do Now

Although the guidance remains a draft, manufacturers can use it to evaluate the strength of their existing development and quality processes.

• 1. Identify essential performance characteristics. Determine which device functions are critical to delivering the intended dose to the intended administration site.
• 2. Review design control documentation. Confirm that performance requirements are traceable to specifications, risk assessments, verification activities, and acceptance criteria.
• 3. Evaluate testing conditions. Ensure verification strategies account for relevant shipping, storage, handling, and use conditions.
• 4. Strengthen manufacturing and supplier controls. Identify materials, components, and processes that could influence essential drug delivery performance.
• 5. Assess change control procedures. Confirm that proposed design, material, supplier, or process changes are evaluated for potential impacts on performance and regulatory requirements.

Bottom Line

FDA’s revised draft guidance reinforces an important principle for drug delivery devices and combination products: consistent drug delivery performance depends on effective design controls, risk management, verification, validation, and manufacturing oversight.

By defining critical performance characteristics early and maintaining appropriate controls throughout the product lifecycle, manufacturers can reduce development uncertainty, improve submission readiness, and better demonstrate that their products consistently perform as intended.

The guidance remains open for public comment through January 28, 2027.

At Quality Solutions Now (QSN), we support medical device, pharmaceutical, biologics, and combination product manufacturers with design controls, risk management, verification and validation, quality system implementation, process improvement, and regulatory readiness.

Our team can help organizations strengthen their development and quality processes to support reliable product performance and evolving FDA expectations.