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By: Scott Gottlieb, M.D. Today, I'm excited to announce, as part of our broader Medical Innovation Access Plan, a new component focused on digital health innovation—the formal launch of our Pre-Cert for Software Pilot Program. This new program embraces the principle that digital health technologies can have significant benefits to patients' lives and to our healthcare system by facilitating prevention, treatment, and diagnosis; and by helping consumers manage chronic conditions outside of traditional healthcare settings. At the same time we are announcing this pilot, FDA's Center for Devices and Radiological Health (CDRH) is publishing its Digital Health Innovation Action Plan to provide details and timelines for our integrated approach to digital health technology and the implementation of the 21st Century Cures Act. We're telling consumers and the digital health industry how we will establish clear and consistent expectations for the products FDA regulates. Continue reading |
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