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FDA Digital Health

Meaning

FDA Digital Health refers to the strategic and regulatory initiatives undertaken by the U.S. Food and Drug Administration (FDA) to oversee and facilitate the development and market entry of digital health technologies. This encompasses software, mobile applications, wearables, and other technologies that function as medical devices, known as Software as a Medical Device (SaMD). The agency’s focus is on ensuring that these rapidly evolving technologies meet the standards for safety, effectiveness, and quality, while simultaneously fostering innovation. The FDA’s efforts are centered in the Digital Health Center of Excellence.