USFDA Draft Guidance: Essential Drug Delivery Performance Characteristics for Drug and Biological Product Delivery Devices
The U.S. Food and Drug Administration (FDA) has issued a revised draft guidance titled “Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products” in October 2026. The document provides recommendations for establishing, evaluating, and maintaining the performance characteristics of devices and combination products used to deliver human drugs, including biological products.
1. Scope and Applicability
The draft guidance applies to drug delivery devices regulated by CDRH and CBER, as well as device constituent parts of CDER-led and CBER-led combination products intended to deliver human drugs, including biological products.
Examples of products covered include:
Prefilled syringes and injectors, including autoinjectors and on-body injectors.
Infusion products, including infusion pumps.
Nasal sprays, inhalers and nebulizers.
Vaginal drug delivery systems.
The guidance focuses specifically on drug delivery performance. It does not cover other areas such as drug-device compatibility, biocompatibility, sterility, human factors, electrical safety, electromagnetic compatibility, wireless technology or cybersecurity. Sponsors should refer to the applicable FDA regulations and guidance documents for these areas.
2. Understanding Essential Drug Delivery Device Performance Characteristics (EDDCs)
The draft guidance introduces the concept of Essential Drug Delivery Device Performance Characteristics (EDDCs). These are the key, system-level device characteristics that require performance data to demonstrate that the intended drug dose is delivered to the intended delivery site.
Drug delivery performance includes successful product preparation and the initiation, progression and completion of dose delivery.
EDDCs depend on the functional design of the device and should be identified based on the product type, intended use, patient population, route of administration, drug characteristics, dosage form and expected performance.
What qualifies as an EDDC?
An EDDC is a high-level drug delivery function that incorporates lower-level component characteristics and depends on the functional design of the device.
For example, in a prefilled syringe, glide force and breakloose force may be EDDCs because they influence the initiation and completion of drug delivery.
What does not qualify as an EDDC?
Component-level characteristics already reflected in a higher-level EDDC, as well as functions dependent on user actions, are generally not considered EDDCs.
For example, silicone quantity and needle inner diameter are not separate EDDCs for the prefilled syringe example. Injection depth is also not an EDDC when it depends on the user's injection technique.
The guidance emphasizes that the examples provided are not automatically applicable to every product. Sponsors should assess their individual device design and intended use when identifying EDDCs.
3. Verification and Validation of EDDC Specifications
FDA recommends that EDDC specifications be supported through appropriate design verification and validation activities to demonstrate that the device consistently performs as intended throughout its lifecycle.
Specifications should include suitable acceptance criteria that are clinically meaningful and appropriate for the intended use and patient population.
Design and Development Verification
Verification should demonstrate that the device meets its specified EDDC requirements under relevant conditions. It generally includes preconditioning followed by verification testing.
Preconditioning should simulate conditions that the product may experience during storage, shipping and use, including:
Storage: Temperature, temperature fluctuations, pressure changes and humidity.
Shipping: Vibration, shock and pressure changes associated with transportation.
Conditions of use: Product preparation, setup, warm-up, cleaning, reprocessing and repeat-use conditions, as applicable.
For reusable devices, testing should consider worst-case repeat-use and reprocessing cycles, including cleaning, sterilisation or disinfection procedures described in the proposed labelling.
Verification Testing and Sampling
Verification testing should assess whether EDDC specifications remain satisfied after appropriate preconditioning.
Sampling plans should be risk-based and consider the intended indication, patient population, drug, context of use and complexity of the device design and manufacturing process. Testing protocols should include a justified statistical sampling plan, including the number of lots and acceptance criteria. The tested lots should represent the final finished product.
Shelf-Life and Stability Testing
EDDCs that may change over time or have age-related failure modes should be evaluated as part of shelf-life and stability testing.
For combination products, the proposed expiration date should be supported by evidence demonstrating that both the EDDC specifications and drug constituent part specifications continue to be met.
Accelerated ageing data may be used where appropriate but should be confirmed by real-time ageing data.
Design and Development Validation
Validation should confirm that the final finished product meets user needs and intended use requirements. Where the device must connect or interface with other medical devices, validation should also assess performance in the connected configuration.
Depending on the application type and product, validation approaches may include clinical studies, pharmacokinetic/pharmacodynamic (PK/PD) studies, bioequivalence or bioavailability studies, and relevant published literature.
Where clinical studies are used, protocols should include endpoints relevant to EDDC performance.
4. Additional Considerations for ANDA, BLA and 510(k) Submissions
The draft guidance provides specific considerations for certain application pathways.
ANDA and Section 351(k) BLA Combination Products
For generic combination products and biosimilar combination products, applicants may be able to use information from the reference listed drug (RLD) or reference product to support EDDC validation.
A side-by-side comparison of EDDC specifications or testing results may be provided. Where differences are identified, additional data may be needed to demonstrate that the proposed performance remains appropriate for the relevant therapeutic equivalence, biosimilarity or interchangeability assessment.
If reference product information is unavailable, applicants are encouraged to contact FDA through appropriate meeting requests or controlled correspondence to discuss a proposed validation approach.
510(k) Submissions
For 510(k) submissions, sponsors should compare the intended use and technological characteristics, including EDDCs, with the predicate device.
Where differences in technological characteristics exist, FDA may request additional performance data, including clinical data when necessary, to assess whether the device is as safe and effective as the predicate.
5. Control Strategies for EDDCs
FDA recommends establishing a control strategy to ensure that each lot of the final finished product consistently meets its EDDC specifications.
Control strategies may include:
Upstream controls: In-process controls, process parameter controls, incoming material controls and purchasing information.
Downstream controls: Final product testing and lot release testing.
Combined controls: A combination of upstream and downstream controls, depending on the EDDC and associated risks.
The control strategy should be based on product and process understanding, supported by risk management activities.
Sponsors should identify appropriate controls for each EDDC and provide justification demonstrating that the selected controls are adequate to maintain the required performance.
For products subject to premarket approval, such as NDA, ANDA, BLA and PMA applications, control strategy information should be included in the application. For 510(k) submissions, such information is generally not included in the submission itself but must be available for FDA review during inspections.
6. Information to Provide in Regulatory Applications
The draft guidance describes EDDC-related information and performance data expected in investigational, marketing and post-market change applications.
IND and IDE Applications
The information should reflect the product's stage of development and demonstrate that the device can deliver the intended dose to the intended site safely and effectively for the proposed investigation.
Relevant information may include:
Device design, description and operating principles.
Identification of safety-related EDDCs and associated risk analysis.
Verification data and, where appropriate, validation information.
Performance testing summaries or complete verification reports for unique or unrecognised test methods.
Manufacturing methods and controls, as applicable.
Where clinical studies are used for device performance validation, the study should use the final finished product and include relevant performance and safety endpoints, including device failures, malfunctions and adverse events.
Marketing Applications
The EDDC information should be organised according to the applicable submission pathway, including PMA, 510(k), De Novo, NDA, ANDA and BLA applications.
FDA recommends providing:
A description of the device design, components and operating principles.
Identification of the applicable EDDCs.
Test protocols, summary reports and supporting performance data for the final finished product.
Preconditioning and shelf-life or stability testing information, where applicable.
A control strategy with supporting justification.
Risk management information covering EDDCs and traceability to the relevant risk analysis.
Sponsors should also justify how the acceptance criteria used for performance testing are clinically meaningful and appropriate for the intended use.
7. Post-Market Changes That May Impact EDDCs
When changes are made to an approved product's design or manufacturing process, sponsors should evaluate whether new EDDCs have been introduced and assess the potential impact on existing EDDC specifications.
The draft guidance recommends that relevant post-market change submissions address:
Description of changes: Compare the proposed design or manufacturing changes with the approved product.
Impact assessment: Evaluate the potential impact on relevant EDDCs and their specifications.
Verification and validation: Provide updated data for affected EDDCs, including preconditioning and stability information where applicable.
Control strategy: Reassess whether existing controls remain effective or whether an updated control strategy is required.
For unchanged EDDC specifications, sponsors should provide appropriate verification information or scientific justification explaining why the specifications are not expected to be adversely affected.
Where specifications change, new verification and validation data should be provided, unless existing information can be scientifically justified and leveraged.
8. Interaction with FDA
FDA encourages sponsors to begin identifying and characterising EDDCs during product development rather than waiting until marketing application preparation.
Sponsors are encouraged to seek FDA feedback on:
Proposed EDDCs and their specifications.
Verification and validation activities.
The proposed control strategy.
The timing of EDDC-related studies in relation to pivotal clinical studies and marketing submissions.
Meeting background packages should clearly describe the product, drug delivery function, intended users and context of use. Sponsors should include specific questions and relevant supporting information to facilitate meaningful discussions with FDA.
9. Examples Provided in the Appendices
The draft guidance includes practical examples to help sponsors identify EDDCs and develop appropriate control strategies.
Prefilled syringes: Examples include deliverable volume, breakloose force, glide force, cap removal force and needle safety feature activation force.
Autoinjectors: Examples include dose accuracy, extended needle length, activation force, injection time and audible or visual feedback.
Other delivery systems: Potential EDDCs are also illustrated for nasal sprays, inhalers, vaginal systems, infusion pumps and subdermal implants.
Control strategy example: Appendix D demonstrates how extended needle length for an autoinjector can be controlled through supplier controls, incoming acceptance, engineering analysis and manufacturing process validation.
These examples are intended to support product-specific assessment and should not be treated as universal EDDC requirements.
10. Draft Guidance Status and Public Comments
The October 2026 document is a revised draft guidance, marked “Draft – Not for Implementation” and containing nonbinding recommendations. It revises the earlier June 2024 draft titled Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products.
The revised version clarifies recommendations on testing and controlling device drug-delivery performance and aligns the content with the revised Quality Management System Regulation (QMSR).
According to the FDA webpage, comments should be submitted by January 28, 2027, using the Federal Register docket number FDA-2024-D-2560. Comments can be submitted electronically through Regulations.gov or in writing to the FDA Dockets Management Staff.
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