Apple, FitBit among companies selected for FDA digital health precertification pilot
November 09, 2017
The program is part of a new digital health action plan the FDA rolled out in July. The agency actively began hiring for its digital health team earlier this month.
It’s all a part of a larger effort to reimagine how the FDA approaches digital health medical device regulation. Consumer technology has been making great strides since the iPhone launched in 2007 and changed how consumers interact with technology on a day-to-day basis. However, medical device regulation under the FDA’s watch hasn’t been updated to reflect this change.