By Vicki G. Norton, Ph.d., Frederick R. Ball and Victoria (Tori) Hawekotte
The U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA would exercise enforcement discretion over participant manufacturers’ digital health devices to improve patient access to digital health technologies. By exercising enforcement discretion, FDA would allow device manufacturers to forego certain marketing requirements, such as labeling and premarket authorization, while participating in the pilot program.
Read the full Alert on the Duane Morris LLP website.