FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate

Abstract

Technological progress in digital therapeutics—and, in particular prescription digital therapeutics (PDTs)—has outpaced the processes that the Food and Drug Administration (FDA) uses to regulate such products. Digital therapeutics have entered the health care ecosystem so rapidly that substantial misunderstandings exist about how they are evaluated and regulated by the FDA. 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. These are important issues because PDTs, and digital therapeutics in general, are an explosively growing field in medicine and offer many advantages over conventional face-to-face treatments for the behavioral dimensions of a wide range of conditions and disease states. By allowing access to evidence-based therapies remotely and privately, digital therapeutics can reduce existing disparities in care and improve health equity. But clinicians, payers, and other healthcare stakeholders must appreciate the rigor of the regulatory frameworks within which PDTs are approved for use.

Disease-Agnostic Electronic Adherence Aid for Subcutaneous at-Home and Self-Administration Devices─The Lowest Common Denominator Based on a Cross-Indication Survey

“…40 While simple adherence tools with no impact on treatment decisions or the dosing regimen may not require dedicated regulatory approval, 41 diagnostic and treatment software would need to be developed according to principles for demonstrating their safety, effectiveness, and performance. 42,43 Another set of barriers foreseen for the implementation of the OnePlatform digital health solution pertains to logistical and operational aspects. The described OnePlatform digital health platform would necessitate seamless integration with the pre-existing healthcare systems, which frequently employ a variety of software and hardware solutions.…”

“…Such tools are referred to as Software as Medical Device (SaMD) by regulators and categorized according to the significance of information provided and the state of healthcare situation or condition . While simple adherence tools with no impact on treatment decisions or the dosing regimen may not require dedicated regulatory approval, diagnostic and treatment software would need to be developed according to principles for demonstrating their safety, effectiveness, and performance. , …”

Redesigning Pharmacy to Improve Public Health Outcomes: Expanding Retail Spaces for Digital Therapeutics to Replace Consumer Products That Increase Mortality and Morbidity Risks

“…DTx are mobile medical apps that received regulatory clearance as “Software as a Medical Device” (SaMD) products for the treatment, diagnosis, or prevention of medical conditions [ 25 , 26 , 27 , 28 , 29 , 30 ]. SaMD is defined as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device” [ 24 ].…”

Anti-amyloid: An antibody to cure Alzheimer’s or an attitude

“…In an exciting advance, prescription digital therapeutics (PDT) are becoming more well studied and even approved by the FDA, which act as a new adjunct therapy to oral drugs. 69 This digital therapy can be utilized to assist treatment or be used prior to disease onset to intervene before symptomatic presentation. The advantage of promoting memory augmentation through a digital health platform, or software as a medical device (SaMD), is that ease of access and time to intervention are significantly expedited.…”