FDA Unveils New Policies On Digital Health Oversight

The U.S. Food and Drug Administration on Thursday unveiled new oversight policies for digital health products, including increasingly popular software used to assist doctors in making treatment decisions.

In a trio of guidance documents, the FDA described its posture on a wide array of computerized health products. They run the gamut from physician-focused software that creates customized treatment plans to consumer-focused software that reminds patients to take medications.

FDA Commissioner Scott Gottlieb heralded the guidances, saying that they will “expand our efforts to encourage innovation in...

Already a subscriber? Click here to view full article