Search Results for FDA digital health

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FDA Offers More Details on Digital Health Precertification Pilot By Zachary Brennan - Published 09 August 2017

The US Food and Drug Administration (FDA) this week sought to answer some frequently asked questions regarding the roll out of its new precertification pilot program for digital health products, which is expected to begin 1 September and only include nine participants.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: digital health, precertification pilot for digital health, FDA digital health

FDA Pilot to Sign Off on Low-Risk Digital Health Products Without Premarket Review By Zachary Brennan - Published 15 June 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review.

Categories: News, US, FDA, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: digital health, FDA digital health, software as a medical device