Digital Therapeutics (DTx) - US FDA Software as a Medical Device (SaMD) Regulatory Pathway, Quality System and Post-Market Surveillance

What Digital Therapeutics (DTx) - US FDA Software as a Medical Device (SaMD) Regulatory Pathway, Quality System and Post-Market Surveillance requires

There is no single binding instrument titled the 'Digital Therapeutics (DTx) Regulatory Framework - FDA, EMA and Global Convergence 2026'. Prescription digital therapeutics are regulated in the United States as Software as a Medical Device (SaMD) / medical devices by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act and FDA device regulations (including 21 CFR Part 820 Quality System Regulation and 21 CFR Part 11 electronic records), with clinical evaluation informed by the IMDRF SaMD framework and, for software functions, FDA digital health guidance. The Digital Therapeutics Alliance (DTA) is a non-profit industry association (merged into ATA Action in 2025), not a regulator or standards body issuing binding rules. This node summarises the FDA SaMD regulatory pathway, quality-system obligations, post-market surveillance and reimbursement considerations.

Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) - the Digital Therapeutics Alliance is a non-profit industry association (merged into ATA Action in 2025), not a regulator · Version: 2.0.0 · Last updated: 2026-06-29

Primary source: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

SHA-256 integrity: cbf9935463144cf03bee02ff19e389ff15b6c559a97d31191456ac8e1a12637e

Primary Citations — 5 traced to source

• U.S. FDA - Software as a Medical Device (SaMD) and digital health device regulation under the Federal Food, Drug, and Cosmetic Act - https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
• IMDRF 'Software as a Medical Device (SaMD): Clinical Evaluation' (IMDRF/SaMD WG/N41) - the international framework for SaMD clinical evaluation

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