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Peer-Reviewed Publication
Front Digit Health2023;51086219.January 1, 2023Journal Article

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

Anthony Watson1, Richard Chapman2, Gigi Shafai3, Yuri A Maricich3
1Regulatory Affairs, Pear Therapeutics (US), Inc., Boston, MA, United States.
2Global Regulatory Affairs - Devices, Sanofi US, Cambridge, MA, United States.
3Medical Affairs, Pear Therapeutics (US), Inc., Boston, MA, United States.
PubMed PMC DOI PDF

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 exp…

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