From the Editor - FDA Releases Draft Guidance for Drug-Delivery Devices

At the end of June, FDA released a draft guidance that is designed to facilitate and streamline development of stand-alone devices and combination products by improving the consistency of drug-delivery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