Success Stories

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

Helping a Digital Therapeutic Client Successfully Navigate the De Novo Regulatory Pathway

Greenleaf Health helped a digital therapeutic company developing cognitive treatments as it navigated the de novo classification request regulatory pathway. Greenleaf experts worked closely with the client to address FDA concerns and requests regarding the digital therapeutic device, helping to clarify the FDA’s questions and recommendations and assisting with drafting written correspondence to the Agency. With Greenleaf’s guidance, the client was able to resolve all outstanding review issues, resulting in the FDA’s decision to grant their de novo request.