When developing a device-drug combination product, what should be evaluated first to determine applicable guidance documents?

In the context of developing a device-drug combination product, the first evaluation should focus on the determination of product design deliverables. This is crucial as it sets the foundation for how the device and drug will interact, defining the specifications and requirements that must be met to ensure safety and efficacy.

By examining the product design deliverables, developers can gain insights into the functionality, intended use, and safety characteristics that the combination product must adhere to. This evaluation influences subsequent decisions regarding regulatory requirements and the specific guidance documents that will apply throughout the development process. Understanding the design deliverables allows for a comprehensive assessment of both device and drug components, ensuring that all aspects of the combination product are taken into consideration.

Focusing on other aspects, such as the approved indications of the drug or the determination of the primary mode of action, while important, comes after establishing design deliverables. Their analysis would rely on the framework provided by the design assessments, making it more logical to prioritize this evaluation first. Similarly, looking at device guidance documents is essential but only after understanding the specific design requirements to ensure that all relevant guidance is appropriately integrated into the development strategy.