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