Posted by Michael Wonder on 30 Oct 2019
Democrats ‘continue to have concerns’ about FDA program to streamline regulation of medical software
30 October 2019 - A trio of Democrats on the Senate health committee, led by presidential candidate Elizabeth Warren, is reiterating concerns with the way the FDA is beginning to regulate certain smartphone apps and other digital health software.
Over the past two years, the agency has been working closely with companies such as Apple and Fitbit to develop and test out a pre-certification program, known as “Pre-cert,” to streamline regulation of certain low-risk digital health products.
