healthcare.digital July 28, 2025
Executive Summary
This report serves as a comprehensive guide for digital health device innovators seeking to navigate the regulatory landscape established by the US Food and Drug Administration (FDA). The FDA is not merely regulating digital health; it is actively shaping and adapting its approach to foster innovation while ensuring the safety and effectiveness of these technologies.
This implies a dynamic regulatory environment that innovators must continuously monitor. Key resources, such as the Digital Health Center of Excellence (DHCoE), are highlighted as central points of contact and information. The report outlines critical regulatory pathways, delves into evolving areas like cybersecurity and real-world evidence, and provides a forward-looking perspective on the future of digital health regulation.
Introduction: FDA’s Commitment to Digital...
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