Yes. FDA classifies Esper and similar products as devices that may be marketed without prior regulatory approval subject to enforcement discretion. This is a designation FDA uses for low-risk products that meet the definition of a software as a medical device, which is the case with Esper. It is important to remember, however, that this is an evolving area of regulation and FDA could change its position in the future.
Written by Ben JohnstonUpdated over a week ago