Introduction

Digital therapeutics (DTx) — software-driven interventions that prevent, manage, or treat disease — are reshaping healthcare delivery. However, regulatory frameworks for these tools vary widely across jurisdictions, creating uncertainty for innovators.

This article explores key regulatory trends and provides actionable insights for DTx companies aiming to succeed in global markets.

Evolving Standards in the United States

The U.S. Food and Drug Administration (FDA) has been proactive in adapting policies for digital health:

• Pre-Certification Pilot Program: Aims to streamline approvals for software-as-a-medical-device (SaMD).

• AI/ML Action Plan: Sets expectations for adaptive algorithms and real-world learning.

Companies should monitor updates to FDA Digital Health Guidance to align their development roadmaps with regulatory expectations.

Navigating European Union MDR

In the EU, digital therapeutics are now subject to the Medical Device Regulation (MDR), which introduces:

• Stricter classification of SaMD

• Expanded clinical evidence requirements

• Post-market surveillance obligations

Failure to comply can delay market access and create legal risks.

Compliance Roadmap for Innovators

1. Engage Regulators Early
   Initiate dialogue with relevant authorities during product development.

2. Design for Transparency
   Prioritize explainable AI and clear documentation to support regulatory review.

3. Plan for Lifecycle Management
   Address how the product will evolve post-launch while maintaining compliance.

Looking Ahead

As DTx matures, global regulatory convergence may emerge — but for now, companies must navigate a patchwork of local rules. Early planning and strategic partnerships will be key to success.

Conclusion

The regulatory landscape for digital therapeutics is complex but navigable. Companies that invest in regulatory intelligence and proactive engagement will be well-positioned to lead in this exciting new era of digital health.