What Digital Therapeutics (DTx) - Regulatory Classification & Market Access (2026) requires
Digital Therapeutics are software-driven interventions that deliver evidence-based therapeutic treatments for medical conditions. They are regulated as medical devices (often SaMD) in most jurisdictions, requiring clinical evidence of safety and efficacy, quality management systems, cybersecurity, and post-market surveillance. Reimbursement pathways (FDA Breakthrough, German DiGA, etc.) increasingly require real-world evidence and health economic data.
Pillar: Medical & Healthcare · Authority: FDA, BfArM (DiGA), TGA, PMDA · Version: 1.0.0 · Last updated:
Primary source: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-therapeutics
SHA-256 integrity: efc1649c76c8e17206d73575dd1f7dbf6e651889ecfd7be26d7e937aa5a0a763
Primary Citations — 4 traced to source
- FDA Digital Health Center of Excellence - Digital Therapeutics Guidance
- BfArM DiGA Fast-Track Pathway (Digital-Gesundheitsanwendungen)
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