Digital Therapeutics Feature Spec Template

Digital therapeutics make clinical claims backed by clinical evidence and are typically FDA-authorized or cleared. A wellness app (meditation, fitness tracking) makes general well-being claims without clinical evidence requirements. The distinction matters for reimbursement (payers reimburse DTx, not wellness apps), regulatory burden (DTx requires QMS, clinical trials), and clinical credibility (DTx is prescribed by a clinician or recommended within a care pathway).

Timeline varies by pathway. De Novo classification (new device type) typically takes 12-18 months from submission. 510(k) clearance (predicate device exists) typically takes 6-12 months. Breakthrough Device designation can accelerate either pathway. The clinical trial itself usually takes 12-24 months. Plan for a 3-5 year timeline from clinical trial protocol to FDA decision for a novel DTx.

Yes, some DTx products operate under FDA enforcement discretion or are authorized for over-the-counter use. The decision depends on the condition being treated, the risk profile of the intervention, and your regulatory strategy. Lower-risk conditions (insomnia, smoking cessation) may qualify for OTC use. Higher-risk conditions (substance use disorders, ADHD) typically require a prescription. Discuss with your regulatory consultant early.

Payers evaluate DTx using similar criteria to pharmaceuticals: clinical evidence (RCT data showing clinically meaningful improvement over control), health economic impact (cost savings from reduced hospitalizations, ER visits, or medication use), and patient experience (adherence rates, satisfaction). Having published RCT results in a peer-reviewed journal is often a prerequisite for formulary discussion.

Define an end-of-treatment protocol. Options include: (a) transition to a maintenance mode with periodic booster sessions, (b) provide the completed skill library for on-demand access indefinitely, (c) generate an end-of-treatment report for the patient and prescriber summarizing outcomes and recommendations, (d) offer re-enrollment if symptoms recur. Avoid abrupt cutoff that leaves patients without tools. ---