A Modern Approach To Digital Health Product Regulation

By Mark Barnes, Gregory Levine and Abram Barth (August 4, 2017, 11:35 AM EDT) -- As part of an overarching initiative to update its regulatory oversight of digital health technologies, the U.S. Food and Drug Administration has announced new plans to streamline the development and availability of high quality digital health products. Acknowledging that "[d]igital health technology has brought new market participants into the medical devices space, and those participants have brought new innovation and manufacturing processes," the FDA plans to modernize its regulation of digital health products by adopting a more efficient, risk-based approach to foster innovation and ensure that these products perform as intended. As part of that effort, the FDA has announced two new programs: the Digital Health Innovation Action Plan and the launch of its Digital Health Software Precertification ("Pre-Cert") Pilot Program. These initiatives were previewed in a blog posting last month by FDA Commissioner Scott Gottlieb, as discussed here....

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