Begin With The End In Mind: Defining A Pathway For Regulatory Success For Devices In Combination Products – Device Focus

By Lauren Richards

The process of achieving a "right first time" regulatory submission requires defining clear end goals: ensuring patient safety, product efficacy, and a streamlined path to market. It's easy to lose sight of these objectives as a project progresses, making a structured approach essential.

A proven method for maintaining focus and collaboration is applying the Four "Hows" of Regulatory Success. This framework guides cross-functional teams and Regulatory Affairs to navigate the complexities of evolving global regulations. Key areas of focus include: establishing early internal and external collaboration, thoroughly understanding the specific requirements for different markets (like US FDA and EU), proactively preparing objective evidence, and utilizing Regulatory Affairs as a strategic partner. Embracing this holistic strategy maximizes efficiency, compliance, and ultimately, market access.