AUTHOR=Watson Anthony , Chapman Richard , Shafai Gigi , Maricich Yuri A. 

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

JOURNAL=Frontiers in Digital Health

VOLUME=Volume 5 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2023.1086219

DOI=10.3389/fdgth.2023.1086219

ISSN=2673-253X

ABSTRACT=Technological progress in digital therapeutics has outpaced the processes that the Food and Drug Administration (FDA) uses to regulate such products. Prescription digital therapeutics have entered the health care ecosystem so rapidly that some uncertainty exists about how rigorously these devices are evaluated and exactly how they are currently regulated by the FDA. This commentary briefly explains the relevant regulatory history of Software as Medical Devices and reviews the current regulatory landscape in which prescription and non-prescription digital therapeutics are approved for use.