Decoding FDA Labeling of Prescription Digital Therapeutics: A Cross-Sectional Regulatory Study.

Abstract

Background Prescription digital therapeutics (PDTs) are software-only, FDA-regulated medical devices prescribed to prevent, manage, or treat disease. Despite increasing FDA clearance, there remains limited understanding of how PDTs are regulated and labeled from a product, sponsor, and indication standpoint. Objective This study aims to conduct the first systematic regulatory labeling analysis of all FDA-cleared PDTs, characterizing their approval pathways, sponsor profiles, clinical indications