Abstract
Prescription digital therapeutics (PDTs) are emerging as a pivotal component of digital healthcare, providing software-based therapies for various diseases. This review aims to analyze the regulatory landscape in the U.S., safety, efficacy, and current challenges of PDTs, focusing on mental health conditions. Relevant articles were searched on PubMed, Google Scholar, ClinicalTrials.gov, and FDA Guidance Documents databases, supplemented by manual searches of reference lists from included studies. Inclusion criteria covered English-language studies on the development and application, therapeutic efficacy, and regulatory guidelines of PDTs in mental health. Data extraction and synthesis were conducted to summarize key findings and trends in the literature. FDA regulatory frameworks for PDTs are evolving through pathways of de novo and 510(k) applications, with patient-centric guidance. Clinical trials and real-world data support PDTs' safety and efficacy, while highlighting regulatory needs. Challenges include payer coverage, patient accessibility, and data privacy concerns. Mixed patient feedback reveals areas for improvement. Limited healthcare provider engagement and payer coverage contributed to financial challenges for PDT manufacturers. Future trends suggest that PDTs will expand beyond mental health. The evolving landscape underscores the need for continued research, regulatory refinement, and collaborative efforts across stakeholders to ensure the successful integration of PDTs into healthcare.