The proliferation of digital mental health tools has necessitated the development of a specific regulatory framework, primarily managed by the U.S. Food and Drug Administration (FDA). The FDA differentiates between low-risk "general wellness" apps, which fall outside their oversight, and those intended to diagnose, mitigate, treat, or prevent a disease, classifying the latter as Software as a Medical Device (SaMD).

Most SaMD in the mental health space are designated as Class II (moderate risk) devices, requiring a demonstration of safety and effectiveness. Authorization is obtained through pathways like the De Novo classification for novel devices or the 510(k)-clearance pathway, where a manufacturer must prove "substantial equivalence" to an already authorized predicate device. A key area of scrutiny is clinical validation: while many devices have underlying evidence, regulators increasingly demand rigorous Randomized Controlled Trials (RCTs) using the final, marketed product and its intended platform to confirm therapeutic claims and build user trust, a critical factor for the maturation of the overall Digital Mental Health Market, as detailed in regulatory analyses, such as the Digital Mental Health Market Global Outlook.