Product Development

Navigating Regulatory Pathways for Digital Therapeutics

Accelerated by increasing acceptance of decentralized medicine ushered in by the pandemic, the digital therapeutics (DTx) market is rising exponentially. In January 2022, a Research And Markets analysis valued the 2021 global market for DTx at $3.35 billion and estimated it would reach $12.1 Billion by 2026.1 In March 2022, Insider Intelligence revised its previous projection for the 2025 global DTx market value from $9 billion to $56 billion.2 Though the predicted values show degrees of variability, the trend lines consistently point to continued rapid expansion.

This quick rise has resulted in a significant degree of uncertainty. In its Digital Health Innovation Action Plan3, the FDA admits that its traditional approach to hardware-based medical devices is not well suited to software as a medical device (SaMD). While the agency is deliberating how best to ensure efficacy and safety in these cases, absence of a universal framework for evaluating DTx has left health care decision makers and digital therapeutics companies to develop criteria on their own. A rapidly changing regulatory stance combined with evolving payer policies toward this new product type leaves developers with many unknowns.

For the purposes of early regulatory planning, the first question that must be answered is whether a device falls into this regulatory category at all. To avoid unnecessarily embarking on a regulatory pathway that may cost considerable time and money, sponsors must be certain of how their products will be identified by regulators. This blog post will help sponsors gain clarity regarding what is and what is not considered a DTx and how to ensure they are following the correct regulatory pathway for their device.

What Is a Digital Therapeutic?

To qualify as a digital therapeutic, a technology must actively help treat, manage, or prevent a disease or disorder. Functionality for general health promotion, monitoring, or diagnosis isn’t enough. These carefully developed software programs are subject to rigorous clinical and regulatory review to ensure evidence-based safety and efficacy. Typically, development entails advanced technology best practices regarding design, user experience, clinical assessment, and data security.

Many health-related apps, programs, and software products seem, at first glance, to fall into this category. However, the criteria for digital therapeutics as opposed to other digital health categories are specific. The following graphic from the Digital Therapeutics Alliance4 explains.

Is This Product a DTx?

Is this product a DTx?


Examples of Prescription Digital Therapeutics

Intended uses for prescription digital therapeutics are becoming more varied every day. Here is a short list of available products. These are all backed by rigorous clinical studies and have demonstrated safety and efficacy.

Software as Medical Device – Examples

SaMD guidance: Premarket FDA review now, Software Pre-Cert Program forthcoming

The current regulatory review pathway for prescription digital therapeutics involves premarket submission of evidence for review, to assure safety and efficacy. Updates to this process are underway to decrease submission content and accelerate review.

The new precertification model is a streamlined evaluation process introduced as the Software Pre-Cert Pilot Program in September 2020. Progress updates5 are available from the FDA. In addition to accelerating premarket reviews, the Pre-Cert program facilitates the use of real-world postmarket data with the goal of encouraging “innovation, timely patient access, and safety and effectiveness over the product lifecycle.”5

By adapting the framework, regulators hope to enable software developers to leverage data efficiently from numerous sources. The model will also allow them to perform software iterations and adaptations rapidly, in accordance with best practices and in response to real-world performance.

Key Takeaways

Digital therapeutics (DTx), a subset categorized as software as a medical device (SaMD), is a new, rapidly expanding market, and its regulatory landscape is still evolving. The above flow chart can help sponsors decide if their device fits into this category. Whether they will need to invest in clinically validated evidence or simply collect information depends on accurate categorization.

At Premier Research, we have expertise in the design and execution of successful product development strategies for digital therapeutics, including how to navigate FDA premarket reviews to help sponsors move forward. Consult us for everything from premarket guidance through DTx clinical studies of safety and efficacy. We’ll also help you collect real-world evidence (RWE) for submissions and demonstrate value for payers.

[1] Research And Markets, 2022. Global Digital Therapeutics Market Report 2022: Analysis & Forecasts 2020-2026 – Market to Reach $12.1 Billion by 2026. [online] GlobeNewswire News Room. Available at: [Accessed 2 June 2022].

[2] Insider Intelligence, 2022. Digital Therapeutics: DTx market trends and companies in the growing digital health industry. [online] Insider Intelligence. Available at: [Accessed 2 June 2022].

[3] U.S. Food and Drug Administration (FDA). Digital Health Innovation Action Plan. [online] Available at: [Accessed March 4, 2020].

[4] Digital Therapeutics Alliance, 2022. DTx Value Assessment & Integration Guide. Version 2.0. [online] Available at: [Accessed 2 June 2022].

[5] U.S. Food and Drug Administration (FDA). Digital Health Software Pre-Cert Program. Available at: [Accessed 2 June 2022].