A company is developing a device-drug combination product. Which should be evaluated FIRST to determine app guidance docs?

When developing a device-drug combination product, the first evaluation should focus on the determination of product design deliverables. This is crucial because understanding the product design deliverables sets the groundwork for how the combination product will function, its intended use, and how it will meet both regulatory and user requirements.

Product design deliverables encompass specifications for the device component, the formulation of the drug component, and how they will interact within the combination product. By establishing these parameters early on, the development team can ensure that they are aligned with regulatory expectations and that all necessary guidance documents relevant to both the device and the drug components can be effectively addressed.

In contrast, while the approved indications of the drug and the determination of primary mode of action are important factors, they are secondary to understanding what needs to be produced and how the product will be designed and manufactured. Similarly, while guidance documents for the device provide valuable regulatory information, the foundational step of outlining product design deliverables is critical for subsequent evaluations and compliance efforts. This foundational knowledge ultimately informs the design and regulatory strategy for the combination product.