De Novo Regulatory Strategy for a First-in-Class PDT

Situation

• First in class Prescription Digital Therapeutic (PDT) required a credible FDA package despite limited precedent.
• Evidence was distributed across multiple studies and needed to be packaged into a cohesive submission strategy to achieve a broad label.

Approach

• Evaluated regulatory pathway options and organized De Novo pathway support.
• Designed evidence package and submission narrative for FDA engagement.
• Synthesized findings across three clinical trials.
• Mined precedent cases to strengthen classification rationale.
• Developed investor materials aligned to the regulatory story.

Outcome

• Established a clear regulatory pathway for a novel product category.
• Improved coherence and defensibility of the submission narrative.
• Enabled consistent communication across regulatory and investor audiences.