Category: FDA Updates

FDA Updates


FDA Proposes Ban on Electrical Stimulation Devices

The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.

Draft Guidances


FDA Establishes Digital Health Advisory Committee

The FDA is establishing a Digital Health Advisory Committee in 2024, comprising experts from various fields, to advise on the safe and effective regulation of digital health technologies like AI, virtual reality, and wearables, aiming to promote innovation while safeguarding public health.