3. Engage regulators
FDA’s invitation to you is to engage early and often when planning studies using sDHTs.
This section provides practical recommendations for sDHT developers and adopters on engaging regulators effectively, supporting teams from startups to large organizations in navigating FDA interactions.
The overarching goal is to turn regulatory discussions into opportunities for success.
FDA’s Beth Kunkowski discusses the importance of regulatory engagement
Death by pilot: How solid evidence can help digital health vendors achieve scale (October 26, 2021)
Success starts with clear objectives and internal alignment
By focusing on early, strategic outreach, this approach helps clarify expectations, align evidence generation, and minimize risks in clinical development. Whether you are validating a digital endpoint or integrating sDHTs into trials, this early approach de-risks your program by addressing uncertainties in validation, context of use, or trial design.
SECTION 3 | ENGAGE REGULATORS
Ready to dive in?
This content integrates patient-focused insights from prior roadmap sections and emphasizes collaboration, ensuring your strategy is aligned and adaptable.
Explores fundamentals like defining engagement objectives and building cross-functional teams for productive regulator interactions.
Dives into selecting pathways, timing considerations, submission materials, and qualification programs.
Details voluntary pathways to establish sDHTs as “fit-for-purpose” tools, enabling reuse across multiple development programs without duplicative regulatory review.
Synthesizes principles through hypothetical scenarios and real-world proof points to illustrate successful navigation of drug, device, and combination product trials.