Postmarket Safety Surveillance of FDA-Cleared Prescription Digital Therapeutics Using the Manufacturer and User Facility Device Experience (MAUDE) Database: A Pharmacovigilance Study.

Abstract

Background and aim Prescription digital therapeutics (PDTs) are software-based medical treatments authorized by the U.S. Food and Drug Administration (FDA) for a range of chronic conditions. As clinical adoption increases, postmarket surveillance becomes essential to ensure safety beyond controlled trial environments. This study aimed to characterize postmarket adverse events and product problems associated with FDA-cleared PDTs using data from the FDA's Manufacturer and User Facility Device Exp