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FDA Announces Digital Health Innovation Plan; Agency to Pilot Risk-Based Regulatory Framework

Posted: June 21, 2017

On June 15, 2017, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is developing a new Digital Health Innovation Plan (the Plan), through which FDA hopes to encourage industry growth by providing more regulatory certainty to device developers. Gottlieb also indicated that the Agency will soon pilot a new, risk-based approach toward regulating digital health technologies.

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