Review Provides Insight Into FDA Regulations and Prescription Digital Therapeutics as Market Expands

As digital technology becomes an integral part of everyday life, digital therapeutics (DTx) continues to expand to manage and treat a spectrum of medical conditions. It is transforming health care delivery for millions of patients and their health care providers.

In a recent publication in Frontiers in Digital Health, the authors provided insight into the growing use of DTx, especially prescription digital therapeutics (PDTs) in health care. Researchers also reviewed the FDA regulatory processes implemented to ensure DTx and PDT efficacy and safety.

The authors wrote, “This review briefly explains the relevant regulatory history of software as medical devices (SaMDs) and reviews the current regulatory landscape in which prescription and non-prescription digital therapeutics are developed and approved for use.”

The authors also noted that due to the speedy growth of PDTs, some individuals remain unaware and uncertain about how PDTs are reviewed and regulated by the FDA. The authors wrote, “By allowing access to evidence-based therapies remotely and privately, digital therapeutics can reduce existing disparities in care and improve health equity.”

The authors also indicated that the use of PDTs offers several benefits and advantages when compared to traditional face-to-face therapies, especially regarding the behavioral and cognitive facets associated with many diseases and conditions, and that prescribers, payers, and other stakeholders in health care must understand the thoroughness of the FDA regulatory frameworks employed for the evaluation and regulation of PDTs to obtain approval.

Additionally, the authors provided information about creating the Digital Health Center of Excellence (DHCoE) as part of the Center for Devices and Radiological Health (CDRH) and its role in the regulatory processes, especially as the number of DTx continues to increase.

The authors also indicated that the FDA must maintain the line between regulated and unregulated products to ensure patients can access safe and effective products.

Finally, the authors indicated, “The FDA, policymakers, research experts, and developers must work together to make FDA policies related to digital therapeutics as nimble, flexible, and dynamic as the technologies themselves. However, reasonable and flexible regulation only works with responsible enforcement by [the] FDA and compliance by the industry.”

Conclusion

As the number of PDTs continues to enter the market, it is important that clinicians and patients are aware of the regulatory processes instituted by the FDA to ensure the efficacy and safety of PDTs, and knowledge about the meticulous and rigorous regulatory processes may also increase the use of PDTs in clinical practice.

Reference

Watson A, Chapman R, Shafai G, Maricich YA. FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate. Front Digit Health. 2023;5:1086219. doi:10.3389/fdgth.2023.1086219