STAT Plus: Democrats ‘continue to have concerns’ about FDA program to streamline regulation of medical software
A trio of Democrats on the Senate health committee, led by presidential candidate Elizabeth Warren (D-Mass.), is reiterating concerns with the way the Food and Drug Administration 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 precertification program, known as “Pre-cert,” to streamline regulation of certain low-risk digital health products. The idea is to shift the FDA’s focus from evaluating digital-health products to evaluating their makers, allowing companies with internal processes that the agency deems safe and high-quality to build some additional products that can reach the market with less or perhaps no regulation.
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