Masterclass: Pediatric Digital Mental Health: FDA Regulation vs. Wellness Product Pathways

Digital mental health solutions are proliferating across consumer and clinical markets, with growing attention to youth populations and their unique needs. This evolving landscape presents a critical regulatory decision point: pursue FDA clearance as a medical device or position as a wellness product. Each pathway involves distinct considerations around evidence standards, marketing claims, implementation models, and market access—with significant implications for developers, clinicians, patients, and healthcare systems.

This discussion will examine the strategic considerations surrounding regulatory pathways for digital mental health solutions, exploring how these choices influence product development, clinical integration, and market adoption while considering the particular complexities that arise in pediatric applications.

Join us to discuss:

• How do regulatory pathway decisions shape evidence generation strategies, clinical integration approaches, and commercial models for digital mental health solutions?
• What factors should guide developers in determining the appropriate regulatory framework based on intended use, claims, and target populations?
• How might regulatory frameworks evolve to better address the unique considerations of digital interventions across the mental health spectrum?