FDA drafts guidance on essential outputs for drug delivery devices

The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing “essential drug delivery outputs” (EDDOs) that deliver consistent performance.

Products that are within the scope of this guidance include syringes, injectors, infusion products, nasal sprays, inhalers, nebulizers, and vaginal delivery systems. Information about the delivery devices must be submitted in the corresponding investigational or marketing application for combination products that rely on a delivery device.

The guidance states that “drug-device combination products may be more complex than their individual constituent parts because, in addition to the individual constituent parts, the interactions of the constituent parts also need to be assessed, characterized, and controlled during product design, development, and production.”

FDA states that identifying EDDOs “may facilitate the development” of combination products by identifying the type of data to submit in applications, which would ensure the “appropriate device design attributes and manufacturing process steps are evaluated during lifecycle changes.” EDDOs can also be used to compare the drug delivery performance and facilitate assessment for bridging or leveraging data across products.

The guidance identifies three processes for developing EDDOs:

Identification of the EDDO defines the device drug-delivery function of the product and focuses design and development efforts to ensure appropriate drug delivery;

Control to ensure the product meets the device drug-delivery function quality standards; and

Maintenance to guarantee that any changes to the product made during clinical development or post-marketing that could adversely impact the EDDO are evaluated.

In the identification stage, applicants should perform design verification activities, such as “preconditioning” studies to confirm that the device’s drug-delivery function is maintained in accordance with its instructions for use.

For example, such preconditioning can include exposing products to multiple stressors that may influence its device drug-delivery function during shipping, storage, and use.

The preconditions to simulate storage may include subjecting the product to specific temperatures, temperature fluctuations, pressure changes, and humidity. During shipping, a product may be exposed to more than one variation of a condition or sequence of conditions, such as ground by truck to air, ground by truck to boat, ground by rail to air to ground by truck. Conditions for simulating storage may include subjecting the product to specific temperatures, temperature fluctuations, pressure changes, and humidity.

For reusable devices, the preconditioning methods should “simulate the worst-case number of repeat use and reprocessing cycles.” Such preconditioning should include cleaning and sterilization, or disinfection methods identified in the proposed labeling.

The guidance states that results from these reports can be provided in a submission.

The guidance also offers examples of developing EDDOs for a prefilled syringe and an autoinjector.

Stakeholders can comment on the draft guidance until 30 September and submitted to FDA-02024-D-2560

Draft guidance

FDA drafts guidance on essential outputs for drug delivery devices

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