{
  "node_id": "digital-therapeutics-dtx-framework-2026",
  "title": "Digital Therapeutics (DTx) - US FDA Software as a Medical Device (SaMD) Regulatory Pathway, Quality System and Post-Market Surveillance",
  "domain": "Medical & Healthcare",
  "version": "2.0.0",
  "last_updated": "2026-06-29",
  "bluf": "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.",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "ai_overlay_2026"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "primary_citations_count": 5
}