As digital health tools enter the mainstream, the agency will seek to support companies new to the regulatory process, said FDA Commissioner Dr. Scott Gottlieb and Dr. Jeff Shuren, director of the Center for Devices and Radiological Health, primarily through its Digital Health Innovation Action Plan and a new software precertification pilot program.
"With these [digital] advances has come a new swath of companies that are investing in these new opportunities," Gottlieb and Shuren said. "These firms may be new to healthcare products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas."
The agency has also proposed creating a Center of Excellence for Digital Health in 2019.
"In establishing our regulatory approach to emerging technologies, such as digital health, we have recognized that we must -- first and foremost -- maintain our scientific gold standard for assuring product safety and effectiveness," Gottlieb and Shuren said.
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