Success Stories

Learn how Greenleaf works with clients to devise effective solutions to their most complex regulatory challenges.

Identifying a Direct Path to Market for a Wellness Software Product

Greenleaf Health provided strategic and tactical advice to an early-stage software as a service (SaaS) start-up developing and commercializing a software product intended for mental health providers and patients. The Greenleaf team reviewed various proposed claims for the client’s product to ensure that the claims would not cause the software to be an FDA-regulated medical device. Specifically, Greenleaf’s experts assessed whether the proposed product claims were appropriate for an unregulated wellness software product as described in the Federal Food, Drug, and Cosmetic Act and in FDA guidance on general wellness products, and provided the client with a regulatory risk assessment for each proposed product claim. After the client determined which product claims it planned to use, Greenleaf worked with them to draft internal documentation to file, outlining why the client believed that each claim was appropriate for an unregulated wellness software product. The company ultimately went straight to market as a general wellness product, saving time and money that they would have incurred had FDA review been required.