FDA Releases Draft Guidance on General Wellness Devices

FDA Releases Draft Guidance on General Wellness Devices

Considering the increased use of technology in monitoring our daily activities and physiological functions, it is reassuring to see that regulatory bodies such as the FDA are making a step toward defining devices and developing guidelines for their respective claims. Many of the devices mentioned in the document are being utilized in studies and combined with electronic patient diary data (ePRO) to get a well-rounded picture of the patient’s state, including both the participant’s perception as well as physiological aspects. If widely accepted, this guidance should help standardize the reporting of study results and claims associated with device use that is currently lacking. The Draft Guidance can be seen here.