At the end of June, FDA released a draft guidance that is designed to facilitate and streamline development of stand-alone devices and combination products by improving the consistency of drug-delivery performance information included in applications and submissions. The guidance covers products with device constituent parts that are intended to deliver drugs and biological products.
According to FDA, the drug-delivery performance information is designed to demonstrate that the device drug-delivery function consistently performs as intended. The guidance includes examples of potential essential drug-delivery outputs for several product types including prefilled syringes, injectors, nasal sprays, and inhalation devices. Per the new guidance, while design verification and validation activities are intended to address all design inputs and outputs, it offers recommendations that are specific to essential drug-delivery outputs (EDDOs). Appropriate verification and validation activities for EDDOs depend on the conditions (e.g., environmental conditions) to which the product will be exposed during production, shipping, storage, and preparation and the conditions associated with use.
Design verification testing should include an evaluation of EDDOs that may change over time or have age-related failure modes. Data provided to support a proposed expiration date should demonstrate that EDDO performance is maintained.
For a combination product, such data can be derived from design verification shelf-life testing, stability testing, or both. In addition, the guidance indicates that the final determination of the expiration date is informed by the maintenance of EDDO performance and drug stability testing.
EDDOs that would not change over time (e.g., physical dimensions such as needle length) would not warrant evaluation.
The testing to support a proposed expiration date should include consideration of the number of repeat uses of the product to deliver the drug and the potential impact of any associated cleaning and re- processing cycles and interim storage between uses.
To support the proposed expiration date for combination products, verifying the performance of certain EDDOs over time may be accomplished by relying on or leveraging drug stability testing results (e.g., for EDDOs subject to chemical degradation such as those for a vaginal system). The guidance includes EDDO output ex- amples for prefilled syringes and autoinjectors as well as tables with potential outputs based on product type. Comments can be submitted through
Read the full Draft Guidance, “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products Guidance for Industry.”
Sherrie Trigg
Editor and Director of Medical Content
Overview
The draft guidance document titled "Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products" by the FDA outlines key recommendations for the design and evaluation of drug delivery devices and combination products that include device components intended for the delivery of human drugs and biological products.
The document emphasizes that it is nonbinding and serves as a framework for industry stakeholders to understand the essential drug delivery outputs (EDDOs) necessary for establishing and assessing drug delivery performance. It highlights the importance of providing comprehensive information and data during the investigational, marketing, and post-market change application processes.
Key sections of the guidance include:
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Introduction: The document introduces the purpose of the guidance, which is to clarify the FDA's current thinking on drug delivery performance information for devices and combination products.
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Design Inputs and Outputs: It outlines the need for clear design input requirements, which are the physical and performance specifications that guide device design. Additionally, it specifies the importance of design output specifications, including device descriptions, engineering drawings, and materials used.
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Verification and Validation: The guidance stresses the necessity of a robust design verification plan and summary report, along with supporting data and traceability. It also discusses the importance of design validation to ensure that the device meets user needs and intended uses.
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Risk Analysis: A section is dedicated to risk analyses, which evaluate the adequacy of the design verification and validation plans, ensuring that potential risks are identified and mitigated.
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Control Strategies: The document provides an example of a control strategy for a specific drug delivery device (an autoinjector), illustrating how manufacturers can manage EDDOs through supplier information and purchasing controls.
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Submission Requirements: It details the information that must be included in applications for New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs), emphasizing the need for a summary of EDDO information in device description documentation.
Overall, this draft guidance aims to enhance the understanding of essential outputs for drug delivery devices, ensuring that manufacturers can effectively demonstrate the safety and efficacy of their products while complying with regulatory requirements. Stakeholders are encouraged to provide comments on the draft to refine the guidance further.
