FDA Center for Digital Excellence discussion
Event Type
Discussion Panel
TimeFriday, April 163:30pm - 4:30pm EDT
LocationDigital Health
DescriptionThe FDA has strict human factors regulations for the development of hardware medical devices. However, there is now a wealth of medically-related apps focused on data acquisition and behavioral change entering app stores. The majority of these apps fit under the category of “General Wellness” applications and do not require FDA approval. As these tools become more complex, the regulatory boundaries between “General Wellness” applications and software medical device applications have become more gray. With this knowledge, the FDA formed the Center for Digital Excellence in September 2020. This panel includes experts from academia, government, and industry, that will discuss the development of more rigorous digital health regulations to ensure the safety and efficacy of digital health products.

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